VILA-COOKE(TM) ANESTHESIA PILLOW

Support, Patient Position

SHARN, INC.

The following data is part of a premarket notification filed by Sharn, Inc. with the FDA for Vila-cooke(tm) Anesthesia Pillow.

Pre-market Notification Details

Device IDK932305
510k NumberK932305
Device Name:VILA-COOKE(TM) ANESTHESIA PILLOW
ClassificationSupport, Patient Position
Applicant SHARN, INC. 4801 GEORGE RD., #180 Tampa,  FL  33634
ContactJohn F Spangler
CorrespondentJohn F Spangler
SHARN, INC. 4801 GEORGE RD., #180 Tampa,  FL  33634
Product CodeCCX  
CFR Regulation Number868.6820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-12
Decision Date1993-10-05

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