The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Pm Pump Compressor.
Device ID | K930509 |
510k Number | K930509 |
Device Name: | PM PUMP COMPRESSOR |
Classification | Compressor, Air, Portable |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | John R Selady |
Correspondent | John R Selady PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | BTI |
CFR Regulation Number | 868.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-01 |
Decision Date | 1994-10-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00855887006511 | K930509 | 000 |