510(k) K983554
K983554 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care, Inc. for the device "ALLDRESS, ABSORBENT FILM DRESSING". The FDA issued a decision of SN on November 10, 1998. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Molnlycke Health Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- November 10, 1998
- Date Received
- October 13, 1998
- 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