The following data is part of a premarket notification filed by Raleigh Lions Clinic For The Blind, Inc. with the FDA for Surgical Adhesive Tape.
| Device ID | K941943 |
| 510k Number | K941943 |
| Device Name: | SURGICAL ADHESIVE TAPE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | RALEIGH LIONS CLINIC FOR THE BLIND, INC. 315 HUBERT ST. Raleigh, NC 27603 -2392 |
| Contact | James W Wells |
| Correspondent | James W Wells RALEIGH LIONS CLINIC FOR THE BLIND, INC. 315 HUBERT ST. Raleigh, NC 27603 -2392 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-21 |
| Decision Date | 1994-06-30 |