ACU-CURETTE

Curette, Surgical, General Use

ACUDERM, INC.

The following data is part of a premarket notification filed by Acuderm, Inc. with the FDA for Acu-curette.

Pre-market Notification Details

Device IDK891334
510k NumberK891334
Device Name:ACU-CURETTE
ClassificationCurette, Surgical, General Use
Applicant ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale,  FL  33309
ContactCharles R Yeh
CorrespondentCharles R Yeh
ACUDERM, INC. 5370 N.W. 35TH TERRACE Ft. Lauderdale,  FL  33309
Product CodeFZS  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-10
Decision Date1989-04-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814105021323 K891334 000
00814105021316 K891334 000
00814105020050 K891334 000
00814105020043 K891334 000
00814105020036 K891334 000
00814105020029 K891334 000
00814105020012 K891334 000
00814105020005 K891334 000

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