The following data is part of a premarket notification filed by Seiler Precision Microscopes with the FDA for Seiler Colposcope, Models 935, 955 And 985.
| Device ID | K101141 |
| 510k Number | K101141 |
| Device Name: | SEILER COLPOSCOPE, MODELS 935, 955 AND 985 |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | SEILER PRECISION MICROSCOPES 3433 TREE CT INDUSTRIAL BLVD St. Louis, MO 63122 |
| Contact | Dan Meyer |
| Correspondent | Dan Meyer SEILER PRECISION MICROSCOPES 3433 TREE CT INDUSTRIAL BLVD St. Louis, MO 63122 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-08-06 |
| Summary: | summary |