The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for Bi-ostetic.
Device ID | K023703 |
510k Number | K023703 |
Device Name: | BI-OSTETIC |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | BERKELEY ADVANCED BIOMATERIALS, INC. 1933 DAVIS ST. SUITE 307 San Leandro, CA 94577 |
Contact | Francois Genin |
Correspondent | Francois Genin BERKELEY ADVANCED BIOMATERIALS, INC. 1933 DAVIS ST. SUITE 307 San Leandro, CA 94577 |
Product Code | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-04 |
Decision Date | 2003-01-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816125021628 | K023703 | 000 |
00858418003379 | K023703 | 000 |
00858418003362 | K023703 | 000 |
00858418003348 | K023703 | 000 |
00858418003331 | K023703 | 000 |
00858418003324 | K023703 | 000 |
00858418003300 | K023703 | 000 |
00858418003294 | K023703 | 000 |
00858418003256 | K023703 | 000 |
00858418003249 | K023703 | 000 |
00858418003232 | K023703 | 000 |
00858418003010 | K023703 | 000 |
00858418003003 | K023703 | 000 |
00858418003386 | K023703 | 000 |
00858418003393 | K023703 | 000 |
00816125021611 | K023703 | 000 |
00816125021604 | K023703 | 000 |
00816125021598 | K023703 | 000 |
00816125021581 | K023703 | 000 |
00816125021574 | K023703 | 000 |
00816125021567 | K023703 | 000 |
00816125021550 | K023703 | 000 |
00858418003966 | K023703 | 000 |
00858418003812 | K023703 | 000 |
00858418003805 | K023703 | 000 |
00858418003799 | K023703 | 000 |
00858418003782 | K023703 | 000 |
00816125024766 | K023703 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BI-OSTETIC 76097625 not registered Dead/Abandoned |
Berkeley Advanced Biomaterials, Inc. 2000-07-28 |