510(k) K772388
K772388 is an FDA 510(k) premarket notification submitted by Edward Weck, Inc. for the device "CONVERSE-GILLIES NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code HXK (Holder, Needle; Orthopedic), a Class I device regulated under 21 CFR 888.4540. Edward Weck, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 20, 1978
- Date Received
- December 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Needle; Orthopedic
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type