The following data is part of a premarket notification filed by Grieshaber & Co. with the FDA for Grieshaber Two Function Manipulator.
| Device ID | K914585 |
| 510k Number | K914585 |
| Device Name: | GRIESHABER TWO FUNCTION MANIPULATOR |
| Classification | Source, Carrier, Fiberoptic Light |
| 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 | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-16 |
| Decision Date | 1992-01-03 |