The following data is part of a premarket notification filed by Porex Medical with the FDA for Porex(tm) Tissue Expander.
Device ID | K870154 |
510k Number | K870154 |
Device Name: | POREX(TM) TISSUE EXPANDER |
Classification | Expander, Skin, Inflatable |
Applicant | POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
Contact | Howard A Mercer,phd |
Correspondent | Howard A Mercer,phd POREX MEDICAL 500 BOHANNON RD. Fairburn, GA 30213 |
Product Code | LCJ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-13 |
Decision Date | 1987-02-24 |