The following data is part of a premarket notification filed by Edward Weck, Inc. with the FDA for Endoscopic Needlholder Cat. Number 114705.
| Device ID | K911272 |
| 510k Number | K911272 |
| Device Name: | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 |
| Classification | Bell, Circumcision |
| Applicant | EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Contact | Glenn M Mattei |
| Correspondent | Glenn M Mattei EDWARD WECK, INC. P.O. BOX 12600 WECK DRIVE Research Triangle Pa, NC 27709 |
| Product Code | FHG |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-22 |
| Decision Date | 1991-07-02 |