The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Disposable Icp Kit Diff. Sizes.
| Device ID | K840003 |
| 510k Number | K840003 |
| Device Name: | DISPOSABLE ICP KIT DIFF. SIZES |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Codman & Shurtleff, Inc. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-04 |
| Decision Date | 1984-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780514817 | K840003 | 000 |
| 10886704036036 | K840003 | 000 |