The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Phase Plus.
Device ID | K963609 |
510k Number | K963609 |
Device Name: | PHASE PLUS |
Classification | Material, Impression |
Applicant | ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
Contact | Evan Dick |
Correspondent | Evan Dick ZHERMACK S.P.A. 7527 WESTMORELAND AVE. St. Louis, MO 63105 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-10 |
Decision Date | 1996-11-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
48033712560333 | K963609 | 000 |
38033712560268 | K963609 | 000 |
38033712560251 | K963609 | 000 |
18033712560233 | K963609 | 000 |
18033712560226 | K963609 | 000 |
18033712560219 | K963609 | 000 |
38033712560275 | K963609 | 000 |
00803371256263 | K963609 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PHASE PLUS 74579970 1916417 Dead/Cancelled |
Huntsman Film Products Corp. 1994-09-29 |
PHASE PLUS 74435944 not registered Dead/Abandoned |
Huntsman Film Products Corp. 1993-09-15 |