510(k) K940768
K940768 is an FDA 510(k) premarket notification submitted by Chimera Research & Chemical, Inc. for the device "AD PERFECT". The FDA issued a decision of Substantially Equivalent on February 17, 1995. The device falls under product code IFT (Glutaraldehyde), a Class I device regulated under 21 CFR 864.4010. Chimera Research & Chemical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1995
- Date Received
- February 18, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glutaraldehyde
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type