The following data is part of a premarket notification filed by Stryker Medical with the FDA for Stryker Operating Room Table.
Device ID | K940068 |
510k Number | K940068 |
Device Name: | STRYKER OPERATING ROOM TABLE |
Classification | Table, Operating-room, Ac-powered |
Applicant | STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
Contact | Chad A Coberly |
Correspondent | Chad A Coberly STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
Product Code | FQO |
CFR Regulation Number | 878.4960 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-01-06 |
Decision Date | 1994-05-05 |