The following data is part of a premarket notification filed by Mick Radio-nuclear Instruments, Inc. with the FDA for Henschke Afterloading Applicator.
Device ID | K871217 |
510k Number | K871217 |
Device Name: | HENSCHKE AFTERLOADING APPLICATOR |
Classification | System, Applicator, Radionuclide, Manual |
Applicant | MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
Contact | Felix W Mick |
Correspondent | Felix W Mick MICK RADIO-NUCLEAR INSTRUMENTS, INC. P.O. BOX 99 Bronx, NY 10465 |
Product Code | IWJ |
CFR Regulation Number | 892.5650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-26 |
Decision Date | 1987-07-16 |