The following data is part of a premarket notification filed by Stryker Medical with the FDA for Stryker 8000 Surgery Stretcher.
Device ID | K943864 |
510k Number | K943864 |
Device Name: | STRYKER 8000 SURGERY STRETCHER |
Classification | Stretcher, Wheeled |
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 | FPO |
CFR Regulation Number | 880.6910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-08 |
Decision Date | 1994-08-25 |