VERSATELL; VERSATELL-S

Device, Biofeedback

PROGRESSIVE CONCEPTS, INC.

The following data is part of a premarket notification filed by Progressive Concepts, Inc. with the FDA for Versatell; Versatell-s.

Pre-market Notification Details

Device IDK941959
510k NumberK941959
Device Name:VERSATELL; VERSATELL-S
ClassificationDevice, Biofeedback
Applicant PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton,  MD  21629
ContactRay Fischer
CorrespondentRay Fischer
PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton,  MD  21629
Product CodeHCC  
CFR Regulation Number882.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-22
Decision Date1995-06-21

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