510(k) K970439
K970439 is an FDA 510(k) premarket notification submitted by Progressive Surgical Products, Inc. for the device "PROXIDERM (D-460,D 90 460,D 180,460, PS 460)". The FDA issued a decision of Substantially Equivalent on April 16, 1997. The device falls under product code MKY (System, Skin Closure), a Class I device regulated under 21 CFR 878.4320. Progressive Surgical Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1997
- Date Received
- February 5, 1997
- 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