AQUALUBE(TM)

Lubricant, Patient

PARKER LABORATORIES, INC.

The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Aqualube(tm).

Pre-market Notification Details

Device IDK864556
510k NumberK864556
Device Name:AQUALUBE(TM)
ClassificationLubricant, Patient
Applicant PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange,  NJ  07050
ContactMartin Buchalter
CorrespondentMartin Buchalter
PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange,  NJ  07050
Product CodeKMJ  
CFR Regulation Number880.6375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-11-19
Decision Date1986-12-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855683006371 K864556 000
30855683006365 K864556 000
20855683006474 K864556 000
10855683006736 K864556 000
10855683006361 K864556 000

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