510(k) K851612
K851612 is an FDA 510(k) premarket notification submitted by Mowbray Co., Inc. for the device "DERMA PREP". The FDA issued a decision of Substantially Equivalent on May 3, 1985. The device falls under product code KGT (Drape, Adhesive, Aerosol), a Class I device regulated under 21 CFR 878.4380.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1985
- Date Received
- April 18, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drape, Adhesive, Aerosol
- Device Class
- Class I
- Regulation Number
- 878.4380
- Review Panel
- HO
- Submission Type