WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM

Speculum, Vaginal, Nonmetal

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach's Ultimate Reusable, Plastic Vaginal Speculum.

Pre-market Notification Details

Device IDK992736
510k NumberK992736
Device Name:WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
ClassificationSpeculum, Vaginal, Nonmetal
Applicant WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange,  CT  06477
ContactMichael Malis
CorrespondentMichael Malis
WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange,  CT  06477
Product CodeHIB  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-08-13
Decision Date1999-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00888937011371 K992736 000

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