HEMO-WEDGE

Instruments, Dental Hand

PARKER LABORATORIES, INC.

The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Hemo-wedge.

Pre-market Notification Details

Device IDK790555
510k NumberK790555
Device Name:HEMO-WEDGE
ClassificationInstruments, Dental Hand
Applicant PARKER LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDZN  
CFR Regulation Number872.4565 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-03-19
Decision Date1980-01-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E29950300 K790555 000
E29950250 K790555 000
E29950249 K790555 000
E29950239 K790555 000
E29950229 K790555 000
E29950219 K790555 000
E29950209 K790555 000

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