The following data is part of a premarket notification filed by Femtek, Inc. with the FDA for Phem-chek.
| Device ID | K960648 |
| 510k Number | K960648 |
| Device Name: | PHEM-CHEK |
| Classification | Paper, Obstetric Ph |
| Applicant | FEMTEK, INC. 50 BELLEFONTAINE ST. Pasadena, CA 91105 -3181 |
| Contact | James C Caillouette, Md |
| Correspondent | James C Caillouette, Md FEMTEK, INC. 50 BELLEFONTAINE ST. Pasadena, CA 91105 -3181 |
| Product Code | LNW |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-14 |
| Decision Date | 1996-05-13 |
| Summary: | summary |