The following data is part of a premarket notification filed by Merivaara Instrumentarium Corp. with the FDA for Futura Junior 300/310.
Device ID | K943262 |
510k Number | K943262 |
Device Name: | FUTURA JUNIOR 300/310 |
Classification | Stretcher, Wheeled |
Applicant | MERIVAARA INSTRUMENTARIUM CORP. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein MERIVAARA INSTRUMENTARIUM CORP. 555 THIRTEENTH ST. N.W. Washington, DC 20004 |
Product Code | FPO |
CFR Regulation Number | 880.6910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-07 |
Decision Date | 1994-09-29 |