510(k) K905105
K905105 is an FDA 510(k) premarket notification submitted by Jain Surgical Equipment, Inc. for the device "JAIN SUTURE/VESIBAND ORGANIZER". The FDA issued a decision of Substantially Equivalent on January 31, 1991. The device falls under product code MDM (Instrument, Manual, Surgical, General Use), 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
- January 31, 1991
- Date Received
- November 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type