510(k) K082208
K082208 is an FDA 510(k) premarket notification submitted by Scivolutions, Inc. for the device "DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER". The FDA issued a decision of Substantially Equivalent on December 1, 2008. The device falls under product code NAC (Dressing, Wound, Hydrophilic), a Class I device regulated under 21 CFR 878.4018. Scivolutions, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 1, 2008
- Date Received
- August 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Hydrophilic
- Device Class
- Class I
- Regulation Number
- 878.4018
- Review Panel
- SU
- Submission Type