The following data is part of a premarket notification filed by Aso Corp. with the FDA for Care Band Antibacterial Bandages.
| Device ID | K983368 |
| 510k Number | K983368 |
| Device Name: | CARE BAND ANTIBACTERIAL BANDAGES |
| Classification | Tape And Bandage, Adhesive |
| 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 | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-24 |
| Decision Date | 1999-02-17 |