K882284 is an FDA 510(k) clearance for the SURGEONS CAP. This device is classified as a Cap, Surgical (Class I - General Controls, product code FYF).
Submitted by A Plus International, Inc. (La Puente, US). The FDA issued a Cleared decision on June 23, 1988, 23 days after receiving the submission on May 31, 1988.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4040.
| 510(k) Number | K882284 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1988 |
| Decision Date | June 23, 1988 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | FYF - Cap, Surgical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4040 |