The following data is part of a premarket notification filed by George Percy Mcgown with the FDA for Endo-tripton, Mechanical Gallstone Crusher.
| Device ID | K860863 |
| 510k Number | K860863 |
| Device Name: | ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER |
| Classification | Lithotriptor, Biliary Mechanical |
| Applicant | GEORGE PERCY MCGOWN 300 S.W. 70 TERRACE PEMBROKE PINES, FL 33023 |
| Product Code | LQC |
| CFR Regulation Number | 876.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-07 |
| Decision Date | 1986-05-15 |