The following data is part of a premarket notification filed by Medical Technique Instruments, Inc. with the FDA for Pink Cassette Caddie.
Device ID | K893728 |
510k Number | K893728 |
Device Name: | PINK CASSETTE CADDIE |
Classification | Cassette, Radiographic Film |
Applicant | MEDICAL TECHNIQUE INSTRUMENTS, INC. 511 SIXTH ST. SOUTH Kirkland, WA 98033 |
Contact | Lou Castagna |
Correspondent | Lou Castagna MEDICAL TECHNIQUE INSTRUMENTS, INC. 511 SIXTH ST. SOUTH Kirkland, WA 98033 |
Product Code | IXA |
CFR Regulation Number | 892.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-17 |
Decision Date | 1989-09-18 |