510(k) K771187
K771187 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "DERMAHOOK #382-805". The FDA issued a decision of Substantially Equivalent on July 11, 1977. The device falls under product code GDG (Hook, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1977
- Date Received
- July 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hook, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type