510(k) K001023
K001023 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Consumer Companies, Inc. for the device "FREEDOM, MODEL 4660". The FDA issued a decision of Substantially Equivalent on September 22, 2000. The device falls under product code SEJ (Wound Dressings Containing Topical Analgesics), a Class U device. Johnson & Johnson Consumer Companies, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 22, 2000
- Date Received
- March 30, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wound Dressings Containing Topical Analgesics
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type
A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.