The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Button Valve.
| Device ID | K911410 |
| 510k Number | K911410 |
| Device Name: | PS MEDICAL BUTTON VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-01 |
| Decision Date | 1991-06-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994908155 | K911410 | 000 |
| 00763000027995 | K911410 | 000 |
| 00763000028954 | K911410 | 000 |
| 00763000028589 | K911410 | 000 |
| 00763000029159 | K911410 | 000 |
| 00673978229027 | K911410 | 000 |
| 00673978229034 | K911410 | 000 |
| 00673978244907 | K911410 | 000 |
| 00673978244921 | K911410 | 000 |
| 00643169466449 | K911410 | 000 |
| 00643169466463 | K911410 | 000 |
| 00643169472853 | K911410 | 000 |
| 00643169482920 | K911410 | 000 |
| 00643169497443 | K911410 | 000 |
| 00643169497450 | K911410 | 000 |
| 00613994908148 | K911410 | 000 |
| 00763000027971 | K911410 | 000 |