The following data is part of a premarket notification filed by Procedure Products, Inc. with the FDA for Male Luer Lock Plugs.
| Device ID | K810921 |
| 510k Number | K810921 |
| Device Name: | MALE LUER LOCK PLUGS |
| Classification | Set, Administration, Intravascular |
| Applicant | PROCEDURE PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-06 |
| Decision Date | 1981-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B16080751 | K810921 | 000 |
| B16080421 | K810921 | 000 |
| B16080391 | K810921 | 000 |
| B16080381 | K810921 | 000 |
| B16080332 | K810921 | 000 |