The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Philips Orthopaedic Applications.
Device ID | K042867 |
510k Number | K042867 |
Device Name: | PHILIPS ORTHOPAEDIC APPLICATIONS |
Classification | System, Image Processing, Radiological |
Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HIGHWAY Bothell, WA 98021 -8431 |
Contact | Lynn T Harmer |
Correspondent | Melissa J Deguia UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2004-10-18 |
Decision Date | 2004-11-02 |
Summary: | summary |