The following data is part of a premarket notification filed by Shield Laboratories, Inc. with the FDA for Catheter Dressing Chance Set.
| Device ID | K771712 |
| 510k Number | K771712 |
| Device Name: | CATHETER DRESSING CHANCE SET |
| Classification | Fiber, Medical, Absorbent |
| Applicant | SHIELD LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRL |
| CFR Regulation Number | 880.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-12 |
| Decision Date | 1977-10-13 |