The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Disposable Plastic Intracranial Press/kit.
| Device ID | K853770 |
| 510k Number | K853770 |
| Device Name: | CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Contact | Donald A Lincoln |
| Correspondent | Donald A Lincoln Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-09 |
| Decision Date | 1986-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780514879 | K853770 | 000 |
| 10381780514831 | K853770 | 000 |
| 10886704036050 | K853770 | 000 |
| 10886704036043 | K853770 | 000 |