The following data is part of a premarket notification filed by Barzell-whitmore Maroon Bells, Inc. with the FDA for Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support And Manual Adjustment Accessory.
| Device ID | K972672 |
| 510k Number | K972672 |
| Device Name: | BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BARZELL-WHITMORE MAROON BELLS, INC. 300 NW 82ND AVE., SUITE 402 Plantation, FL 33324 |
| Contact | Marian Harding Cochran |
| Correspondent | Marian Harding Cochran BARZELL-WHITMORE MAROON BELLS, INC. 300 NW 82ND AVE., SUITE 402 Plantation, FL 33324 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1997-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841436111812 | K972672 | 000 |
| 00841436110402 | K972672 | 000 |
| 00841436110419 | K972672 | 000 |
| 00841436101240 | K972672 | 000 |
| 00841436105286 | K972672 | 000 |
| 00841436105316 | K972672 | 000 |
| 00841436105347 | K972672 | 000 |
| 00841436105408 | K972672 | 000 |
| 00841436105804 | K972672 | 000 |
| 00841436107341 | K972672 | 000 |
| 00841436111027 | K972672 | 000 |
| 00841436104661 | K972672 | 000 |