The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Siphonguard Csf Control Device.
Device ID | K992173 |
510k Number | K992173 |
Device Name: | SIPHONGUARD CSF CONTROL DEVICE |
Classification | Shunt, Central Nervous System And Components |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | Laura O'grady |
Correspondent | Laura O'grady JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-28 |
Decision Date | 2000-04-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10381780520191 | K992173 | 000 |
10886704041801 | K992173 | 000 |
10886704041795 | K992173 | 000 |
10886704041788 | K992173 | 000 |
10886704041771 | K992173 | 000 |
10886704041658 | K992173 | 000 |
10886704041641 | K992173 | 000 |
10886704041634 | K992173 | 000 |
10886704041627 | K992173 | 000 |
10886704041610 | K992173 | 000 |
10381780519393 | K992173 | 000 |
10381780519782 | K992173 | 000 |
10381780519775 | K992173 | 000 |
10381780519430 | K992173 | 000 |
10886704041818 | K992173 | 000 |
10886704041962 | K992173 | 000 |
10886704042082 | K992173 | 000 |
10381780520177 | K992173 | 000 |
10381780520160 | K992173 | 000 |
10886704042051 | K992173 | 000 |
10886704041993 | K992173 | 000 |
10886704041986 | K992173 | 000 |
10381780520078 | K992173 | 000 |
10381780520061 | K992173 | 000 |
10886704041955 | K992173 | 000 |
10886704042099 | K992173 | 000 |
10886704042075 | K992173 | 000 |
10886704042068 | K992173 | 000 |
10886704041979 | K992173 | 000 |
10381780519416 | K992173 | 000 |