BURNFREE PAIN RELIEVING GEL, MODEL 4B

Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

NORTRADE MEDICAL, INC.

The following data is part of a premarket notification filed by Nortrade Medical, Inc. with the FDA for Burnfree Pain Relieving Gel, Model 4b.

Pre-market Notification Details

Device IDK990178
510k NumberK990178
Device Name:BURNFREE PAIN RELIEVING GEL, MODEL 4B
ClassificationDressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Applicant NORTRADE MEDICAL, INC. 9382 SOUTH 670 WEST Sandy,  UT  84070
ContactJay W Taylor
CorrespondentJay W Taylor
NORTRADE MEDICAL, INC. 9382 SOUTH 670 WEST Sandy,  UT  84070
Product CodeMGQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-01-20
Decision Date1999-08-13

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