510(k) K885136
K885136 is an FDA 510(k) premarket notification submitted by Sorex Medical for the device "GRAFT GUARD". The FDA issued a decision of Substantially Equivalent on February 6, 1989. The device falls under product code LZM (Guard, Skin Graft), a Class I device regulated under 21 CFR 878.4014. Sorex Medical has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 1989
- Date Received
- December 15, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Guard, Skin Graft
- Device Class
- Class I
- Regulation Number
- 878.4014
- Review Panel
- SU
- Submission Type