The following data is part of a premarket notification filed by Donald G. Zeller with the FDA for Pap Smear Brush.
Device ID | K832986 |
510k Number | K832986 |
Device Name: | PAP SMEAR BRUSH |
Classification | Spatula, Cervical, Cytological |
Applicant | DONALD G. ZELLER 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HHT |
CFR Regulation Number | 884.4530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-01 |
Decision Date | 1984-02-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20888937009938 | K832986 | 000 |
30888937003285 | K832986 | 000 |
30888937003179 | K832986 | 000 |
30888937003186 | K832986 | 000 |
30888937003193 | K832986 | 000 |
30888937003209 | K832986 | 000 |
30888937003216 | K832986 | 000 |
30888937003223 | K832986 | 000 |
30888937003230 | K832986 | 000 |
20888937009891 | K832986 | 000 |
20888937009907 | K832986 | 000 |
20888937009914 | K832986 | 000 |
20888937009921 | K832986 | 000 |
30888937003278 | K832986 | 000 |