The following data is part of a premarket notification filed by Atc Technologies, Inc. with the FDA for Sparrowhawk Disposable.
| Device ID | K010473 |
| 510k Number | K010473 |
| Device Name: | SPARROWHAWK DISPOSABLE |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | ATC TECHNOLOGIES, INC. 80 CUMMINGS PARK Woburn, MA 01801 |
| Contact | Paul Kierce |
| Correspondent | Paul Kierce ATC TECHNOLOGIES, INC. 80 CUMMINGS PARK Woburn, MA 01801 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-20 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817428020615 | K010473 | 000 |
| 00817428020370 | K010473 | 000 |
| 00817428020356 | K010473 | 000 |
| 00817428020325 | K010473 | 000 |
| 00817428020318 | K010473 | 000 |
| 00817428020295 | K010473 | 000 |
| 00817428020271 | K010473 | 000 |
| 00817428020257 | K010473 | 000 |
| 00817428020233 | K010473 | 000 |
| 00817428020219 | K010473 | 000 |
| 00817428020394 | K010473 | 000 |
| 00817428020417 | K010473 | 000 |
| 00817428020592 | K010473 | 000 |
| 00817428020578 | K010473 | 000 |
| 00817428020554 | K010473 | 000 |
| 00817428020530 | K010473 | 000 |
| 00817428020516 | K010473 | 000 |
| 00817428020493 | K010473 | 000 |
| 00817428020479 | K010473 | 000 |
| 00817428020455 | K010473 | 000 |
| 00817428020431 | K010473 | 000 |
| 00817428020196 | K010473 | 000 |