The following data is part of a premarket notification filed by Medi-physics Inc. Dba Nycomed Amersham Imaging with the FDA for Sdmo Applicator Code: Asn.8236.
| Device ID | K921961 |
| 510k Number | K921961 |
| Device Name: | SDMO APPLICATOR CODE: ASN.8236 |
| Classification | System, Applicator, Radionuclide, Manual |
| 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 | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-27 |
| Decision Date | 1992-07-01 |