The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Suction Pattie.
Device ID | K901937 |
510k Number | K901937 |
Device Name: | CODMAN SUCTION PATTIE |
Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
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 | GCX |
CFR Regulation Number | 880.6740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-30 |
Decision Date | 1990-07-16 |