The following data is part of a premarket notification filed by Gyn-disposables, Inc. with the FDA for Gyn Disposables Tenaculum 356t.
| Device ID | K073182 |
| 510k Number | K073182 |
| Device Name: | GYN DISPOSABLES TENACULUM 356T |
| Classification | Tenaculum, Uterine |
| Applicant | GYN-DISPOSABLES, INC. 2671 APPLING ROAD Memphis, TN 38133 -5001 |
| Contact | James K Patterson |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | HDC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-11-13 |
| Decision Date | 2007-11-28 |
| Summary: | summary |