The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Pm Pump Aspirator.
Device ID | K932494 |
510k Number | K932494 |
Device Name: | PM PUMP ASPIRATOR |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | John Selady |
Correspondent | John Selady PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-24 |
Decision Date | 1993-10-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00815871020350 | K932494 | 000 |
00815871020343 | K932494 | 000 |