The following data is part of a premarket notification filed by Barzell-whitmore Maroon Bells, Inc. with the FDA for Barzell-whitmore Maroon Bells, Inc. Colo-rectal Mover, Model 3900.
| Device ID | K000960 |
| 510k Number | K000960 |
| Device Name: | BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BARZELL-WHITMORE MAROON BELLS, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Contact | Art Ward |
| Correspondent | Art Ward BARZELL-WHITMORE MAROON BELLS, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-24 |
| Decision Date | 2000-05-26 |