The following data is part of a premarket notification filed by Polamedco, Inc. with the FDA for Gastric, Catheter, Irrigation & Aspiration.
| Device ID | K933596 |
| 510k Number | K933596 |
| Device Name: | GASTRIC, CATHETER, IRRIGATION & ASPIRATION |
| Classification | Tube, Nasogastric |
| Applicant | POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Contact | Jerry W Harrer |
| Correspondent | Jerry W Harrer POLAMEDCO, INC. 8295 S.LA CIENEGA BLVD. Inglewood, CA 90301 -1521 |
| Product Code | BSS |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-26 |
| Decision Date | 1995-02-13 |