The following data is part of a premarket notification filed by Medi-physics Inc. Dba Nycomed Amersham Imaging with the FDA for I-125 Rapid Strand.
Device ID | K940632 |
510k Number | K940632 |
Device Name: | I-125 RAPID STRAND |
Classification | Source, Isotope, Sealed, Gold, Titanium, Platinum |
Applicant | MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 2636 S. CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Kathryn B Patterson |
Correspondent | Kathryn B Patterson MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING 2636 S. CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | IWI |
CFR Regulation Number | 892.5730 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-14 |
Decision Date | 1994-09-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
I-125 RAPID STRAND 74492878 2001773 Dead/Cancelled |
AMERSHAM INTERNATIONAL PLC 1994-02-22 |