510(k) K923351
K923351 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "SKIN SUPPORT PREP PAD". The FDA issued a decision of Substantially Equivalent on September 14, 1992. The device falls under product code KOX (Solvent, Adhesive Tape), a Class I device regulated under 21 CFR 878.4730. Coloplast Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1992
- Date Received
- July 8, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solvent, Adhesive Tape
- Device Class
- Class I
- Regulation Number
- 878.4730
- Review Panel
- SU
- Submission Type