HISTOBRUSH

Spatula, Cervical, Cytological

PURITAN MEDICAL PRODUCTS COMPANY LLC

The following data is part of a premarket notification filed by Puritan Medical Products Company Llc with the FDA for Histobrush.

Pre-market Notification Details

Device IDK111681
510k NumberK111681
Device Name:HISTOBRUSH
ClassificationSpatula, Cervical, Cytological
Applicant PURITAN MEDICAL PRODUCTS COMPANY LLC 31 SCHOOL ST. Guilford,  ME  04443
ContactWilliam M Young
CorrespondentWilliam M Young
PURITAN MEDICAL PRODUCTS COMPANY LLC 31 SCHOOL ST. Guilford,  ME  04443
Product CodeHHT  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-15
Decision Date2012-01-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00609576325045 K111681 000
00609576325038 K111681 000
50609576250083 K111681 000
30609576250072 K111681 000

Trademark Results [HISTOBRUSH]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HISTOBRUSH
HISTOBRUSH
76483871 2852813 Live/Registered
Puritan Medical Products Company LLC
2003-01-21
HISTOBRUSH
HISTOBRUSH
76249024 not registered Dead/Abandoned
Hardwood Products Company LP
2001-05-01
HISTOBRUSH
HISTOBRUSH
74113340 1669286 Dead/Cancelled
SPECTRUM LABORATORIES, INC.
1990-11-08
HISTOBRUSH
HISTOBRUSH
73828299 not registered Dead/Abandoned
SPECTRUM LABORATORIES, INC.
1989-09-29

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