The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Quick Shunt Kit, Cat. #82-6570.
| Device ID | K934196 |
| 510k Number | K934196 |
| Device Name: | CODMAN QUICK SHUNT KIT, CAT. #82-6570 |
| Classification | Endoscope, Neurological |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Amy Walters |
| Correspondent | Amy Walters Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-26 |
| Decision Date | 1994-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886704044635 | K934196 | 000 |
| 10886704044321 | K934196 | 000 |
| 10886704044314 | K934196 | 000 |
| 10886704044307 | K934196 | 000 |