SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK

Elastomer, Silicone Block

SPECTRUM DESIGNS, INC.

The following data is part of a premarket notification filed by Spectrum Designs, Inc. with the FDA for Spectrum Designs Pre-form Contour Silicone Carving Block.

Pre-market Notification Details

Device IDK982688
510k NumberK982688
Device Name:SPECTRUM DESIGNS PRE-FORM CONTOUR SILICONE CARVING BLOCK
ClassificationElastomer, Silicone Block
Applicant SPECTRUM DESIGNS, INC. 6387 B ROSE LN. Carpineteria,  CA  93013
ContactJim Dishman
CorrespondentJim Dishman
SPECTRUM DESIGNS, INC. 6387 B ROSE LN. Carpineteria,  CA  93013
Product CodeMIB  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-03
Decision Date1998-10-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724CCB7SC3L1 K982688 000
M724CCB5S551 K982688 000
M724CCB5S541 K982688 000
M724CCB5S531 K982688 000
M724CCB5S521 K982688 000
M724CCB5S511 K982688 000
M724CCB7C3RSIZNS1 K982688 000
M724CCB7C3LSIZNS K982688 000
M724CCB7C2RSIZNS1 K982688 000
M724CCB5S561 K982688 000
M724CCB6S711 K982688 000
M724CCB7SC2R1 K982688 000
M724CCB7SC2L1 K982688 000
M724CCB7SC1R1 K982688 000
M724CCB7SC1L1 K982688 000
M724CCB7S611 K982688 000
M724CCB6S741 K982688 000
M724CCB6S731 K982688 000
M724CCB6S721 K982688 000
M724CCB7C2LSIZNS1 K982688 000
M724CCB7C1RSIZNS1 K982688 000
M724CCB7C1LSIZNS1 K982688 000
M724CCB673SIZNS1 K982688 000
M724CCB672SIZNS1 K982688 000
M724CCB671SIZNS1 K982688 000
M724CCB556SIZNS1 K982688 000
M724CCB555SIZNS1 K982688 000
M724CCB554SIZNS1 K982688 000
M724CCB553SIZNS1 K982688 000
M724CCB552SIZNS1 K982688 000
M724CCB674SIZNS1 K982688 000
M724CCB711SIZNS1 K982688 000
M724CCB791SIZNS1 K982688 000
M724CCB781SIZNS1 K982688 000
M724CCB771SIZNS1 K982688 000
M724CCB761SIZNS1 K982688 000
M724CCB751SIZNS1 K982688 000
M724CCB741SIZNS1 K982688 000
M724CCB731SIZNS1 K982688 000
M724CCB721SIZNS1 K982688 000
M724CCB551SIZNS1 K982688 000
M724CCB7SC3R1 K982688 000
M724CCB7TC3R1 K982688 000
M724CCB7S311 K982688 000
M724CCB7S211 K982688 000
M724CCB7S111 K982688 000
M724CCB6T841 K982688 000
M724CCB6T831 K982688 000
M724CCB6T741 K982688 000
M724CCB6T731 K982688 000
M724CCB6T711 K982688 000
M724CCB7S511 K982688 000
M724CCB7S711 K982688 000
M724CCB7TC3L1 K982688 000
M724CCB7TC1L1 K982688 000
M724CCB7T911 K982688 000
M724CCB7T711 K982688 000
M724CCB7T611 K982688 000
M724CCB7T411 K982688 000
M724CCB7T311 K982688 000
M724CCB7S811 K982688 000
M724CCB5T531 K982688 000
M724CCB5T521 K982688 000
M724CCB5T511 K982688 000
M724CCB6T721 K982688 000
M724CCB5T561 K982688 000
M724CCB5T551 K982688 000
M724CCB5T541 K982688 000
M724CCB6S851 K982688 000
M724CCB6S841 K982688 000
M724CCB6S831 K982688 000
M724CCB6S821 K982688 000
M724CCB6T811 K982688 000
M724CCB6T821 K982688 000
M724CCB7TC2R1 K982688 000
M724CCB7TC2L1 K982688 000
M724CCB7TC1R1 K982688 000
M724CCB7T811 K982688 000
M724CCB7T511 K982688 000
M724CCB7T211 K982688 000
M724CCB7S911 K982688 000
M724CCB7S411 K982688 000
M724CCB6S811 K982688 000

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