The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Csf-flow Control Valve, Ultra Small.
| Device ID | K873247 |
| 510k Number | K873247 |
| Device Name: | CSF-FLOW CONTROL VALVE, ULTRA SMALL |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 928 GARDEN ST. Santa Barbara, CA 93101 |
| Contact | Stephen W Laquette |
| Correspondent | Stephen W Laquette PUDENZ-SCHULTE MEDICAL RESEARCH CORP. 928 GARDEN ST. Santa Barbara, CA 93101 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-14 |
| Decision Date | 1987-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994908766 | K873247 | 000 |
| 00643169466104 | K873247 | 000 |
| 00643169466098 | K873247 | 000 |
| 00643169466081 | K873247 | 000 |
| 00673978249193 | K873247 | 000 |
| 00673978249186 | K873247 | 000 |
| 00673978249179 | K873247 | 000 |
| 00673978228891 | K873247 | 000 |
| 00673978228860 | K873247 | 000 |
| 00673978228853 | K873247 | 000 |
| 00763000027704 | K873247 | 000 |
| 00763000027698 | K873247 | 000 |
| 00763000027681 | K873247 | 000 |
| 00763000029715 | K873247 | 000 |
| 00763000029708 | K873247 | 000 |
| 00643169472372 | K873247 | 000 |
| 00643169472389 | K873247 | 000 |
| 00613994908759 | K873247 | 000 |
| 00613994908742 | K873247 | 000 |
| 00613994965882 | K873247 | 000 |
| 00643169507548 | K873247 | 000 |
| 00643169497498 | K873247 | 000 |
| 00643169483934 | K873247 | 000 |
| 00643169483620 | K873247 | 000 |
| 00643169483613 | K873247 | 000 |
| 00643169483606 | K873247 | 000 |
| 00643169483286 | K873247 | 000 |
| 00643169483279 | K873247 | 000 |
| 00643169473362 | K873247 | 000 |
| 00643169472402 | K873247 | 000 |
| 00643169472396 | K873247 | 000 |
| 00763000029692 | K873247 | 000 |