The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Pharm 100% Silicone Foley Cath Temperature Probe.
| Device ID | K853207 |
| 510k Number | K853207 |
| Device Name: | PHARM 100% SILICONE FOLEY CATH TEMPERATURE PROBE |
| Classification | Catheter, Urological |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Lawrence W Getlin |
| Correspondent | Lawrence W Getlin 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 | 1985-07-31 |
| Decision Date | 1985-09-12 |