510(k) K894996
K894996 is an FDA 510(k) premarket notification submitted by Controlled Therapeutics Corp. for the device "EXUSORB(TM) GRANULES". The FDA issued a decision of Substantially Equivalent on September 28, 1989. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Controlled Therapeutics Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 1989
- Date Received
- August 8, 1989
- 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