The following data is part of a premarket notification filed by Cedar Surgical, Inc. with the FDA for Cedar(tm) Retractor Ring.
Device ID | K873691 |
510k Number | K873691 |
Device Name: | CEDAR(TM) RETRACTOR RING |
Classification | Retractor, Self-retaining, For Neurosurgery |
Applicant | CEDAR SURGICAL, INC. 15265 MINNETONKA BLVD. Minnetonka, MN 55345 |
Contact | Terry P Corbin |
Correspondent | Terry P Corbin CEDAR SURGICAL, INC. 15265 MINNETONKA BLVD. Minnetonka, MN 55345 |
Product Code | GZT |
CFR Regulation Number | 882.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-08 |
Decision Date | 1987-09-28 |