The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Easygo Aspirator.
Device ID | K971749 |
510k Number | K971749 |
Device Name: | EASYGO ASPIRATOR |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | Conley Wallace |
Correspondent | Conley Wallace 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 | 1997-05-12 |
Decision Date | 1998-04-01 |