510(k) K895606
K895606 is an FDA 510(k) premarket notification submitted by Controlled Therapeutics Corp. for the device "EXUSORB(TM) GEL DRESSING". The FDA issued a decision of SN on October 19, 1989. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Controlled Therapeutics Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- October 19, 1989
- Date Received
- September 18, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type