The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Instrument Clamps Electromagnetic.
Device ID | K202609 |
510k Number | K202609 |
Device Name: | Instrument Clamps Electromagnetic |
Classification | Ear, Nose, And Throat Stereotaxic Instrument |
Applicant | Stryker Corporation Boetzinger Strasse 41 Freiburg, DE D-79111 |
Contact | Maya Schiel |
Correspondent | Maya Schiel Stryker Corporation Boetzinger Strasse 41 Freiburg, DE D-79111 |
Product Code | PGW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-09 |
Decision Date | 2020-10-09 |