The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Lhalo Split Ring Retractor System.
Device ID | K913233 |
510k Number | K913233 |
Device Name: | CODMAN LHALO SPLIT RING RETRACTOR SYSTEM |
Classification | Retractor, Self-retaining, For Neurosurgery |
Applicant | Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Contact | Thomas J Courage |
Correspondent | Thomas J Courage Codman & Shurtleff, Inc. 41 PACELLA PARK DR. RANDOLPH INDUSTRIAL PARK Randolph, MA 02368 -1794 |
Product Code | GZT |
CFR Regulation Number | 882.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-22 |
Decision Date | 1991-07-31 |