K853155 is an FDA 510(k) clearance for the BOEHRINGER LAB SUCTION INTERRUPTER. This device is classified as a Regulator, Vacuum (Class II - Special Controls, product code KDP).
Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on October 16, 1985, 79 days after receiving the submission on July 29, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K853155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1985 |
| Decision Date | October 16, 1985 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KDP — Regulator, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |