The following data is part of a premarket notification filed by Porex Surgical, Inc. with the FDA for Medpor Contain Can Implant.
Device ID | K102184 |
510k Number | K102184 |
Device Name: | MEDPOR CONTAIN CAN IMPLANT |
Classification | Barrier, Synthetic, Intraoral |
Applicant | POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
Contact | Stephanie Fullard |
Correspondent | Stephanie Fullard POREX SURGICAL, INC. 15 DART RD. Newnan, GA 30265 |
Product Code | NPK |
CFR Regulation Number | 872.3930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-08-02 |
Decision Date | 2011-01-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07613252204480 | K102184 | 000 |
07613252204466 | K102184 | 000 |
07613252204459 | K102184 | 000 |