The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pharmaseal Rubber Urethral Catheter.
Device ID | K874517 |
510k Number | K874517 |
Device Name: | PHARMASEAL RUBBER URETHRAL 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 | 1987-11-02 |
Decision Date | 1987-12-03 |