Submission Details
| 510(k) Number | K760521 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 1976 |
| Decision Date | November 12, 1976 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
K760521 is an FDA 510(k) clearance for the TAPE MEASURE, a Caliper (Class I — General Controls, product code KTZ), submitted by Mcgaw Laboratories (Walker, US). The FDA issued a Cleared decision on November 12, 1976, 78 days after receiving the submission on August 26, 1976. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4150.
| 510(k) Number | K760521 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 1976 |
| Decision Date | November 12, 1976 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KTZ — Caliper |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 888.4150 |