The following data is part of a premarket notification filed by Stryker Communications Corp. with the FDA for Stryker Switchpoint Infinity.
Device ID | K033132 |
510k Number | K033132 |
Device Name: | STRYKER SWITCHPOINT INFINITY |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | STRYKER COMMUNICATIONS CORP. 12140 COMMUNITY ROAD Poway, CA 92020 |
Contact | Nathan Woodcock |
Correspondent | Nathan Woodcock STRYKER COMMUNICATIONS CORP. 12140 COMMUNITY ROAD Poway, CA 92020 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-30 |
Decision Date | 2004-09-02 |
Summary: | summary |