The following data is part of a premarket notification filed by Life Medical Sciences, Inc. with the FDA for Sure-closure 75mm Skin Stretching System.
| Device ID | K926127 |
| 510k Number | K926127 |
| Device Name: | SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM |
| Classification | Stapler, Surgical |
| Applicant | LIFE MEDICAL SCIENCES, INC. 1300 NORTH 17TH ST. SUITE 300 Arlington, VA 22209 |
| Contact | Glenn A Rahmoeller |
| Correspondent | Glenn A Rahmoeller LIFE MEDICAL SCIENCES, INC. 1300 NORTH 17TH ST. SUITE 300 Arlington, VA 22209 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-04 |
| Decision Date | 1993-06-24 |