The following data is part of a premarket notification filed by Puritan Medical Products Company Llc with the FDA for Histobrush.
Device ID | K111681 |
510k Number | K111681 |
Device Name: | HISTOBRUSH |
Classification | Spatula, Cervical, Cytological |
Applicant | PURITAN MEDICAL PRODUCTS COMPANY LLC 31 SCHOOL ST. Guilford, ME 04443 |
Contact | William M Young |
Correspondent | William M Young PURITAN MEDICAL PRODUCTS COMPANY LLC 31 SCHOOL ST. Guilford, ME 04443 |
Product Code | HHT |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-15 |
Decision Date | 2012-01-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00609576325045 | K111681 | 000 |
00609576325038 | K111681 | 000 |
50609576250083 | K111681 | 000 |
30609576250072 | K111681 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HISTOBRUSH 76483871 2852813 Live/Registered |
Puritan Medical Products Company LLC 2003-01-21 |
HISTOBRUSH 76249024 not registered Dead/Abandoned |
Hardwood Products Company LP 2001-05-01 |
HISTOBRUSH 74113340 1669286 Dead/Cancelled |
SPECTRUM LABORATORIES, INC. 1990-11-08 |
HISTOBRUSH 73828299 not registered Dead/Abandoned |
SPECTRUM LABORATORIES, INC. 1989-09-29 |