The following data is part of a premarket notification filed by Intl. Medication Systems, Ltd. with the FDA for The California Splint.
Device ID | K854752 |
510k Number | K854752 |
Device Name: | THE CALIFORNIA SPLINT |
Classification | Blood Pressure Cuff |
Applicant | INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
Contact | Diane Gillett |
Correspondent | Diane Gillett INTL. MEDICATION SYSTEMS, LTD. 1886 SANTA ANITA AVE. South El Monte, CA 91733 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-26 |
Decision Date | 1985-12-17 |