The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Coopersurgical Digital Colposcopy System.
| Device ID | K972630 |
| 510k Number | K972630 |
| Device Name: | COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | COOPERSURGICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer COOPERSURGICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-14 |
| Decision Date | 1998-02-02 |
| Summary: | summary |