The following data is part of a premarket notification filed by Life Medical Sciences, Inc. with the FDA for Sure-closure Ii 75mm Skin Stretching System.
| Device ID | K942526 |
| 510k Number | K942526 |
| Device Name: | SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM |
| Classification | System, Skin Closure |
| Applicant | LIFE MEDICAL SCIENCES, INC. 214 CARNEGIE CENTER Princeton, NJ 08540 |
| Contact | Glenn A Rahmoeller |
| Correspondent | Glenn A Rahmoeller LIFE MEDICAL SCIENCES, INC. 214 CARNEGIE CENTER Princeton, NJ 08540 |
| Product Code | MKY |
| CFR Regulation Number | 878.4320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-27 |
| Decision Date | 1994-07-19 |