VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM

Apparatus, Exhaust, Surgical

VALLEYLAB, INC.

The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Valleylab Optimumm Smoke Evacuator System.

Pre-market Notification Details

Device IDK980915
510k NumberK980915
Device Name:VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM
ClassificationApparatus, Exhaust, Surgical
Applicant VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
ContactCharles M Copperberg
CorrespondentCharles M Copperberg
VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder,  CO  80301
Product CodeFYD  
CFR Regulation Number878.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-11
Decision Date1998-06-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884524001104 K980915 000
10884524001128 K980915 000
10884524001135 K980915 000
10884524001555 K980915 000
20884524001439 K980915 000
10884524000893 K980915 000
10884524001449 K980915 000
10884524001753 K980915 000
20884524000319 K980915 000
10884521134140 K980915 000
20884524001071 K980915 000
10884524000329 K980915 000
10884524000879 K980915 000
10884524000886 K980915 000
10884524001081 K980915 000
20884524001095 K980915 000
10884524001111 K980915 000

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