The following data is part of a premarket notification filed by U. S. A. Medical Corp. with the FDA for Usa Aspirator.
Device ID | K862751 |
510k Number | K862751 |
Device Name: | USA ASPIRATOR |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | U. S. A. MEDICAL CORP. 1569 W. 2650 S. SUITE 7 Ogden, UT 84401 |
Contact | Ted Hillstead |
Correspondent | Ted Hillstead U. S. A. MEDICAL CORP. 1569 W. 2650 S. SUITE 7 Ogden, UT 84401 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-22 |
Decision Date | 1986-08-04 |