The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Model #535 Pacu Stretcher/bed & #530 Ed/trauma Str.
Device ID | K894335 |
510k Number | K894335 |
Device Name: | MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR |
Classification | Syringe, Piston |
Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Contact | John Oldiges |
Correspondent | John Oldiges MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-14 |
Decision Date | 1989-09-12 |