The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for O.b. Basin Set.
| Device ID | K843982 |
| 510k Number | K843982 |
| Device Name: | O.B. BASIN SET |
| Classification | Wrap, Sterilization |
| Applicant | PRO-LAB, INC. POST OFFICE BOX 11276 Birmingham, AL 35201 |
| Contact | Dan Mcdonald |
| Correspondent | Dan Mcdonald PRO-LAB, INC. POST OFFICE BOX 11276 Birmingham, AL 35201 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-11 |
| Decision Date | 1984-10-31 |