The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Surgical Granule Implants.
| Device ID | K982040 |
| 510k Number | K982040 |
| Device Name: | MEDPOR SURGICAL GRANULE IMPLANTS |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Contact | Howard Mercer |
| Correspondent | Howard Mercer POREX SURGICAL, INC. 4715 ROOSEVELT HWY. College Park, GA 30349 -2417 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-10 |
| Decision Date | 1998-09-08 |
| Summary: | summary |