The following data is part of a premarket notification filed by Renfrew Tape, Ltd. with the FDA for Medical Tape.
| Device ID | K912623 |
| 510k Number | K912623 |
| Device Name: | MEDICAL TAPE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | RENFREW TAPE, LTD. 170 RENFREW AVENUE WEST Renfrew, Ontario, CA K7v 2y6 |
| Contact | Robert Sargent |
| Correspondent | Robert Sargent RENFREW TAPE, LTD. 170 RENFREW AVENUE WEST Renfrew, Ontario, CA K7v 2y6 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-13 |
| Decision Date | 1991-11-27 |