510(k) K791573
K791573 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "JELONET PARAFFIN GAUZE DRESSINGS". The FDA issued a decision of Substantially Equivalent on September 4, 1979. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Acme United Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1979
- Date Received
- August 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type