The following data is part of a premarket notification filed by Hancock Laboratories, Inc. with the FDA for Hancock * Obturators.
| Device ID | K801885 |
| 510k Number | K801885 |
| Device Name: | HANCOCK * OBTURATORS |
| Classification | Sizer, Heart-valve, Prosthesis |
| Applicant | HANCOCK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTI |
| CFR Regulation Number | 870.3945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-07 |
| Decision Date | 1980-09-09 |