The following data is part of a premarket notification filed by Theragenics Corp. with the FDA for Modified Palladium Seed Model 100.
| Device ID | K874787 |
| 510k Number | K874787 |
| Device Name: | MODIFIED PALLADIUM SEED MODEL 100 |
| Classification | Source, Isotope, Sealed, Gold, Titanium, Platinum |
| Applicant | THERAGENICS CORP. 900 ATLANTIC DRIVE, N.W. Atlanta, GA 30318 |
| Contact | William H Duffell |
| Correspondent | William H Duffell THERAGENICS CORP. 900 ATLANTIC DRIVE, N.W. Atlanta, GA 30318 |
| Product Code | IWI |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-23 |
| Decision Date | 1987-12-22 |