510(k) K760521
K760521 is an FDA 510(k) premarket notification submitted by Mcgaw Laboratories for the device "TAPE MEASURE". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code KTZ (Caliper), a Class I device regulated under 21 CFR 888.4150. Mcgaw Laboratories has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1976
- Date Received
- August 26, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Caliper
- Device Class
- Class I
- Regulation Number
- 888.4150
- Review Panel
- OR
- Submission Type