The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Retinal Tack And Sutherland Tack Forcep.
Device ID | K897119 |
510k Number | K897119 |
Device Name: | GRIESHABER RETINAL TACK AND SUTHERLAND TACK FORCEP |
Classification | Clip, Tantalum, Ophthalmic |
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 | HQW |
CFR Regulation Number | 886.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-26 |
Decision Date | 1990-04-12 |