510(k) K971126
K971126 is an FDA 510(k) premarket notification submitted by Innovative Technologies , Ltd. for the device "HYDROCOLLOID WOUND DRESSINGS". The FDA issued a decision of Substantially Equivalent on June 24, 1997. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Innovative Technologies , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 1997
- Date Received
- March 27, 1997
- 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