The following data is part of a premarket notification filed by Elantec, Inc. with the FDA for Elantec's Surgical Tape Remover.
| Device ID | K902009 |
| 510k Number | K902009 |
| Device Name: | ELANTEC'S SURGICAL TAPE REMOVER |
| Classification | Solvent, Adhesive Tape |
| Applicant | ELANTEC, INC. 85 SOUTH UNION BLVD. STE. G-160 Lakewood, CO 80228 -2207 |
| Contact | Allen, Phd |
| Correspondent | Allen, Phd ELANTEC, INC. 85 SOUTH UNION BLVD. STE. G-160 Lakewood, CO 80228 -2207 |
| Product Code | KOX |
| CFR Regulation Number | 878.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-03 |
| Decision Date | 1990-08-29 |