The following data is part of a premarket notification filed by Aso Corp. with the FDA for Xyz Pads.
Device ID | K933159 |
510k Number | K933159 |
Device Name: | XYZ PADS |
Classification | Gauze/sponge, Internal |
Applicant | ASO CORP. 300 SARASOTA CENTER BLVD. Sarasota, FL 34240 |
Contact | Joan Rubendall |
Correspondent | Joan Rubendall ASO CORP. 300 SARASOTA CENTER BLVD. Sarasota, FL 34240 |
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 | 1993-06-29 |
Decision Date | 1993-12-13 |