The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Aspirator, Continuous & Programmable Intermittent.
| Device ID | K951423 |
| 510k Number | K951423 |
| Device Name: | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Contact | Leslie H Sherman |
| Correspondent | Leslie H Sherman IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-27 |
| Decision Date | 1995-04-18 |