The following data is part of a premarket notification filed by Pgk, Inc. with the FDA for Pgk Device (modified).
| Device ID | K980997 |
| 510k Number | K980997 |
| Device Name: | PGK DEVICE (MODIFIED) |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | PGK, INC. 8320 OLD COURTHOUSE RD. SUITE 150 Vienna, VA 22182 |
| Contact | Panos G Koutrouvelis |
| Correspondent | Panos G Koutrouvelis PGK, INC. 8320 OLD COURTHOUSE RD. SUITE 150 Vienna, VA 22182 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-17 |
| Decision Date | 1998-09-28 |
| Summary: | summary |