The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Hakim Micro Precision Valve.
| Device ID | K973774 |
| 510k Number | K973774 |
| Device Name: | CODMAN HAKIM MICRO PRECISION VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-03 |
| Decision Date | 1997-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780519942 | K973774 | 000 |
| 10886704041207 | K973774 | 000 |
| 10886704041184 | K973774 | 000 |
| 10886704041177 | K973774 | 000 |
| 10886704041160 | K973774 | 000 |
| 10886704041146 | K973774 | 000 |
| 10886704041139 | K973774 | 000 |
| 10886704041122 | K973774 | 000 |
| 10886704041115 | K973774 | 000 |
| 10886704041108 | K973774 | 000 |
| 10381780518792 | K973774 | 000 |
| 10381780518778 | K973774 | 000 |
| 10381780518709 | K973774 | 000 |
| 10381780518662 | K973774 | 000 |
| 10381780518785 | K973774 | 000 |
| 10886704041214 | K973774 | 000 |
| 10886704041221 | K973774 | 000 |
| 10886704041443 | K973774 | 000 |
| 10886704041436 | K973774 | 000 |
| 10886704041429 | K973774 | 000 |
| 10381780519072 | K973774 | 000 |
| 10886704041405 | K973774 | 000 |
| 10886704041191 | K973774 | 000 |
| 10381780518747 | K973774 | 000 |
| 10381780518730 | K973774 | 000 |
| 10381780518723 | K973774 | 000 |
| 10886704041153 | K973774 | 000 |
| 10886704041948 | K973774 | 000 |
| 10886704041412 | K973774 | 000 |
| 10886704041245 | K973774 | 000 |
| 10886704041238 | K973774 | 000 |
| 10381780518693 | K973774 | 000 |