The following data is part of a premarket notification filed by Liaoning-usa Corp. with the FDA for Gauze Sponges Absorbent Gauze Rolls.
Device ID | K910623 |
510k Number | K910623 |
Device Name: | GAUZE SPONGES ABSORBENT GAUZE ROLLS |
Classification | Gauze/sponge, Internal |
Applicant | LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
Contact | Jay A Brown |
Correspondent | Jay A Brown LIAONING-USA CORP. 123 WEST BELLEVUE, UNIT#4 Pasadena, CA 91105 -2549 |
Product Code | EFQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-13 |
Decision Date | 1991-04-01 |