The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Trypsin 1%.
| Device ID | K771955 |
| 510k Number | K771955 |
| Device Name: | TRYPSIN 1% |
| Classification | Trypsin |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IBG |
| CFR Regulation Number | 864.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-17 |
| Decision Date | 1977-11-22 |