The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Viscoelastic Injection System.
Device ID | K890783 |
510k Number | K890783 |
Device Name: | GRIESHABER VISCOELASTIC INJECTION SYSTEM |
Classification | Pump, Infusion |
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 | FRN |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-15 |
Decision Date | 1989-05-16 |