510(k) K942526
K942526 is an FDA 510(k) premarket notification submitted by Life Medical Sciences, Inc. for the device "SURE-CLOSURE II 75MM SKIN STRETCHING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 19, 1994. The device falls under product code MKY (System, Skin Closure), a Class I device regulated under 21 CFR 878.4320. Life Medical Sciences, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1994
- Date Received
- May 27, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Skin Closure
- Device Class
- Class I
- Regulation Number
- 878.4320
- Review Panel
- SU
- Submission Type