The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Pm3000 & Pm3100 Vacuum Regulator.
| Device ID | K922817 |
| 510k Number | K922817 |
| Device Name: | PM3000 & PM3100 VACUUM REGULATOR |
| Classification | Regulator, Vacuum |
| Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Contact | Michael A Krupa |
| Correspondent | Michael A Krupa PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
| Product Code | KDP |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-11 |
| Decision Date | 1993-03-04 |