The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Global Control Tubing Set.
Device ID | K863444 |
510k Number | K863444 |
Device Name: | GRIESHABER GLOBAL CONTROL TUBING SET |
Classification | Unit, Phacofragmentation |
Applicant | GRIESHABER & CO. 1056 TRENTON RD. P.O. BOX 807 Fallisington, PA 19054 |
Contact | John E Richmond |
Correspondent | John E Richmond GRIESHABER & CO. 1056 TRENTON RD. P.O. BOX 807 Fallisington, PA 19054 |
Product Code | HQC |
CFR Regulation Number | 886.4670 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-08 |
Decision Date | 1986-10-31 |