The following data is part of a premarket notification filed by Precision Medical, Inc. with the FDA for Easy Go Vac.
Device ID | K140179 |
510k Number | K140179 |
Device Name: | EASY GO VAC |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Contact | James Parker |
Correspondent | James Parker PRECISION MEDICAL, INC. 300 HELD DR. Northampton, PA 18067 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-01-24 |
Decision Date | 2014-04-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00855887006603 | K140179 | 000 |