The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Antimicrobial Foley Catheter.
| Device ID | K871429 |
| 510k Number | K871429 |
| Device Name: | ANTIMICROBIAL FOLEY CATHETER |
| Classification | Catheter, Urological |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Robert T Merrick |
| Correspondent | Robert T Merrick AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-09 |
| Decision Date | 1987-08-10 |