510(k) K843788
K843788 is an FDA 510(k) premarket notification submitted by Hermitage Hospital Products, Inc. for the device "CUSTOM BURN DRESSING KIT". The FDA issued a decision of Substantially Equivalent on November 7, 1984. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Hermitage Hospital Products, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 1984
- Date Received
- September 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type