Submission Details
| 510(k) Number | K823076 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 19, 1982 |
| Decision Date | January 12, 1983 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
Cleared
Traditional
SATOBAN FIRST AID TAPE
Jan 1983
Decision
85d
Days
Class 1
Risk
About This 510(k) Submission
K823076 is an FDA 510(k) clearance for the SATOBAN FIRST AID TAPE, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Food and Drug Service, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1983, 85 days after receiving the submission on October 19, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.
Device Classification
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5240 |
Manufacturer
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