510(k) K781091
K781091 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "KNEE INSTRUMENTATION, CONDYLAR". The FDA issued a decision of Substantially Equivalent on July 17, 1978. The device falls under product code HWT (Template), a Class I device regulated under 21 CFR 888.4800. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1978
- Date Received
- July 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Template
- Device Class
- Class I
- Regulation Number
- 888.4800
- Review Panel
- OR
- Submission Type