The following data is part of a premarket notification filed by Beech Medical Products, Inc. with the FDA for Pro-lok Extension Set.
| Device ID | K933852 |
| 510k Number | K933852 |
| Device Name: | PRO-LOK EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BEECH MEDICAL PRODUCTS, INC. 16 SOUTH STATE ST. Newtown, PA 18940 |
| Contact | John Romano |
| Correspondent | John Romano BEECH MEDICAL PRODUCTS, INC. 16 SOUTH STATE ST. Newtown, PA 18940 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-06 |
| Decision Date | 1993-12-29 |