K940798 is an FDA 510(k) clearance for the SHIPPERT PRESSURE BANDAGE, a Tape And Bandage, Adhesive (Class I — General Controls, product code KGX), submitted by Denver Splint Co. (Englewood, US). The FDA issued a Cleared decision on September 28, 1994, 218 days after receiving the submission on February 22, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5240.
| 510(k) Number | K940798 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 22, 1994 |
| Decision Date | September 28, 1994 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGX — Tape And Bandage, Adhesive |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.5240 |