The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Wireless Hand Control, Eg1a (wireless-hc), Receiver For Wireless Hand Control, Eg1a (receiver-hc).
Device ID | K220485 |
510k Number | K220485 |
Device Name: | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver For Wireless Hand Control, EG1A (RECEIVER-HC) |
Classification | Motor, Drill, Electric |
Applicant | The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 |
Contact | Marie Ferrier |
Correspondent | Marie Ferrier Synthes GmbH Eimattstrasse 3 Oberdorf, CH 4436 |
Product Code | HBC |
CFR Regulation Number | 882.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-17 |
Decision Date | 2022-05-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00845384018766 | K220485 | 000 |
00845384018759 | K220485 | 000 |