The following data is part of a premarket notification filed by Porex Medical with the FDA for Porex Nerve Locator.
Device ID | K872791 |
510k Number | K872791 |
Device Name: | POREX NERVE LOCATOR |
Classification | Stimulator, Nerve |
Applicant | POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
Contact | Mercer, Phd |
Correspondent | Mercer, Phd POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
Product Code | ETN |
CFR Regulation Number | 874.1820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-14 |
Decision Date | 1987-10-20 |