510(k) K922659
K922659 is an FDA 510(k) premarket notification submitted by Miltex Instrument Co. for the device "GENERAL SURGERY CLAMP AND NEEDLE HOLDER". The FDA issued a decision of Substantially Equivalent on July 21, 1992. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Miltex Instrument Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1992
- Date Received
- June 3, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type