The following data is part of a premarket notification filed by Chimera Research & Chemical, Inc. with the FDA for Ad Perfect.
Device ID | K940768 |
510k Number | K940768 |
Device Name: | AD PERFECT |
Classification | Glutaraldehyde |
Applicant | CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
Contact | Jack V Smith |
Correspondent | Jack V Smith CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 Seminole, FL 33775 |
Product Code | IFT |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-18 |
Decision Date | 1995-02-17 |