510(k) K870053
K870053 is an FDA 510(k) premarket notification submitted by Jerome Medical for the device "TORQUEDRIVER WRENCH". The FDA issued a decision of Substantially Equivalent on March 11, 1987. The device falls under product code HXC (Wrench), a Class I device regulated under 21 CFR 888.4540. Jerome Medical has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1987
- Date Received
- January 7, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrench
- Device Class
- Class I
- Regulation Number
- 888.4540
- Review Panel
- OR
- Submission Type