The following data is part of a premarket notification filed by Team Technologies, Inc. with the FDA for Cytology Brush.
| Device ID | K971849 |
| 510k Number | K971849 |
| Device Name: | CYTOLOGY BRUSH |
| Classification | Spatula, Cervical, Cytological |
| Applicant | TEAM TECHNOLOGIES, INC. 5949 COMMERCE BLVD. Morristown, TN 37814 |
| Contact | Bob Walton |
| Correspondent | Bob Walton TEAM TECHNOLOGIES, INC. 5949 COMMERCE BLVD. Morristown, TN 37814 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1997-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813360023035 | K971849 | 000 |
| 50813360023023 | K971849 | 000 |
| 00813360023011 | K971849 | 000 |