510(k) K954728
K954728 is an FDA 510(k) premarket notification submitted by Continental Medical Laboratories, Inc. for the device "PROD NO. 01-1694 - 4X4 FOAM DRESSING". The FDA issued a decision of SN on September 23, 1996. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Continental Medical Laboratories, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- September 23, 1996
- Date Received
- October 13, 1995
- 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