The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Magnesium Product No's, 112-01, 112-02.
Device ID | K991761 |
510k Number | K991761 |
Device Name: | MAGNESIUM PRODUCT NO'S, 112-01, 112-02 |
Classification | Photometric Method, Magnesium |
Applicant | A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
Contact | Luis P Leon |
Correspondent | Luis P Leon A.P. TOTAL CARE, INC. 70 HAWLEY AVE, PO BOX 6216 Bridgeport, CT |
Product Code | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-05-24 |
Decision Date | 1999-09-02 |