510(k) K964231
K964231 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)". The FDA issued a decision of Substantially Equivalent on March 10, 1997. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1997
- Date Received
- October 23, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type