K951420 is an FDA 510(k) clearance for the INCASE EXTENSIBLE BAG--NON-STERILE. This device is classified as a Accessory, Surgical Apparel (Class I - General Controls, product code LYU).
Submitted by Alpha Surgical, Inc. (Eau Claire, US). The FDA issued a Cleared decision on June 8, 1995, 73 days after receiving the submission on March 27, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K951420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1995 |
| Decision Date | June 08, 1995 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LYU — Accessory, Surgical Apparel |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |