The following data is part of a premarket notification filed by A.p. Total Care, Inc. with the FDA for Inorganic Phosphorus (ip), Product No's, 112-01, 112-02.
Device ID | K991867 |
510k Number | K991867 |
Device Name: | INORGANIC PHOSPHORUS (IP), PRODUCT NO'S, 112-01, 112-02 |
Classification | Phosphomolybdate (colorimetric), Inorganic Phosphorus |
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 | CEO |
CFR Regulation Number | 862.1580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-01 |
Decision Date | 1999-08-02 |