The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Air/fluid Tubing Set.
Device ID | K914587 |
510k Number | K914587 |
Device Name: | GRIESHABER AIR/FLUID TUBING SET |
Classification | Device, Irrigation, Ocular Surgery |
Applicant | GRIESHABER & CO. 3000 CABOT BLVD. WEST P.O. BOX 1099 Langhorne, PA 19047 |
Contact | John E Richmond |
Correspondent | John E Richmond GRIESHABER & CO. 3000 CABOT BLVD. WEST P.O. BOX 1099 Langhorne, PA 19047 |
Product Code | KYG |
CFR Regulation Number | 886.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-16 |
Decision Date | 1992-01-23 |