The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Innovasis Cranial System.
Device ID | K141644 |
510k Number | K141644 |
Device Name: | INNOVASIS CRANIAL SYSTEM |
Classification | Plate, Cranioplasty, Preformed, Alterable |
Applicant | INNOVASIS, INC. 614 E 3900 S Salt Lake City, UT 84107 |
Contact | Marshall Mccarty |
Correspondent | Marshall Mccarty INNOVASIS, INC. 614 E 3900 S Salt Lake City, UT 84107 |
Product Code | GWO |
Subsequent Product Code | GXR |
Subsequent Product Code | HBW |
CFR Regulation Number | 882.5320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-19 |
Decision Date | 2014-11-07 |
Summary: | summary |