The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ps Medical Delta Burr Hole Valve.
| Device ID | K934545 |
| 510k Number | K934545 |
| Device Name: | PS MEDICAL DELTA BURR HOLE VALVE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIVERSITY BUSINESS CENTER 125-B CREMONA DRIVE Goleta, CA 93117 |
| Contact | Tom Holdych |
| Correspondent | Tom Holdych PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIVERSITY BUSINESS CENTER 125-B CREMONA DRIVE Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-22 |
| Decision Date | 1994-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994908506 | K934545 | 000 |
| 00673978228082 | K934545 | 000 |
| 00681490915335 | K934545 | 000 |
| 00643169466609 | K934545 | 000 |
| 00643169466838 | K934545 | 000 |
| 00643169466845 | K934545 | 000 |
| 00643169496682 | K934545 | 000 |
| 00643169496699 | K934545 | 000 |
| 00643169496705 | K934545 | 000 |
| 00643169496712 | K934545 | 000 |
| 00643169496729 | K934545 | 000 |
| 00643169496736 | K934545 | 000 |
| 00643169496903 | K934545 | 000 |
| 00643169073685 | K934545 | 000 |
| 00643169073715 | K934545 | 000 |
| 00643169073722 | K934545 | 000 |
| 00643169073746 | K934545 | 000 |
| 00643169073753 | K934545 | 000 |
| 00763000028121 | K934545 | 000 |