510(k) K934839
K934839 is an FDA 510(k) premarket notification submitted by Richard Hamer Assoc., Inc. for the device "MESALT STERILE DRESSING". The FDA issued a decision of Substantially Equivalent on December 22, 1993. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Richard Hamer Assoc., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1993
- Date Received
- October 8, 1993
- 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