510(k) K881084
K881084 is an FDA 510(k) premarket notification submitted by Med-Dex Intl. for the device "UTILITY CLAMP". The FDA issued a decision of Substantially Equivalent on Mar 25, 1988. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Med-Dex Intl. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 25, 1988
- Date Received
- Mar 14, 1988
- 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
- 510(k) Exempt