The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Impact Model 323 Aspirator.
| Device ID | K133196 |
| 510k Number | K133196 |
| Device Name: | IMPACT MODEL 323 ASPIRATOR |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Contact | Alan Giordano |
| Correspondent | Alan Giordano IMPACT INSTRUMENTATION, INC. 27 FAIRFIELD PL. P.O. BOX 508 West Caldwell, NJ 07006 -0508 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-03-10 |
| Summary: | summary |