510(k) K904536
K904536 is an FDA 510(k) premarket notification submitted by Jain Surgical Equipment, Inc. for the device "JAIN GRAFT ASSIST". The FDA issued a decision of Substantially Equivalent on November 29, 1990. The device falls under product code GCZ (Retainer, Surgical), a Class I device regulated under 21 CFR 878.4800. Jain Surgical Equipment, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1990
- Date Received
- October 4, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retainer, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type