The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Koh Colpotomizer System.
| Device ID | K954311 |
| 510k Number | K954311 |
| Device Name: | KOH COLPOTOMIZER SYSTEM |
| Classification | Culdoscope (and Accessories) |
| Applicant | COOPERSURGICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara COOPERSURGICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | HEW |
| CFR Regulation Number | 884.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-15 |
| Decision Date | 1996-11-19 |
| Summary: | summary |