RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE

Wrap, Sterilization

AMSCO STERILE RECOVERIES, INC.

The following data is part of a premarket notification filed by Amsco Sterile Recoveries, Inc. with the FDA for Recoveries Autoclavable Resuable Wrap -- Fac. Use.

Pre-market Notification Details

Device IDK931874
510k NumberK931874
Device Name:RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE
ClassificationWrap, Sterilization
Applicant AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater,  FL  34621
ContactDenise A Schottler
CorrespondentDenise A Schottler
AMSCO STERILE RECOVERIES, INC. 28100 U.S. HWY, 19N., STE. 201 Clearwater,  FL  34621
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-14
Decision Date1994-06-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850057346053 K931874 000
00850057346046 K931874 000
00850057346039 K931874 000
00850057346022 K931874 000

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