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 |