The following data is part of a premarket notification filed by Anderson Winn Paper Co. with the FDA for Cell Collecting Brush.
Device ID | K924908 |
510k Number | K924908 |
Device Name: | CELL COLLECTING BRUSH |
Classification | Spatula, Cervical, Cytological |
Applicant | ANDERSON WINN PAPER CO. P.O. BOX 7609 14937 SAN FERNANDO MISSION BLV Mission Hills, CA 91345 |
Contact | Ned Buckman |
Correspondent | Ned Buckman ANDERSON WINN PAPER CO. P.O. BOX 7609 14937 SAN FERNANDO MISSION BLV Mission Hills, CA 91345 |
Product Code | HHT |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-30 |
Decision Date | 1993-04-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00187207000283 | K924908 | 000 |
00187207000382 | K924908 | 000 |
00187207000412 | K924908 | 000 |
20187207000362 | K924908 | 000 |
20187207000393 | K924908 | 000 |
20187207000423 | K924908 | 000 |
30187207000437 | K924908 | 000 |
00187207000245 | K924908 | 000 |
00187207000276 | K924908 | 000 |
00187207000351 | K924908 | 000 |