The following data is part of a premarket notification filed by Waterstone Medical, Inc. with the FDA for Omni-jug.
| Device ID | K952200 |
| 510k Number | K952200 |
| Device Name: | OMNI-JUG |
| Classification | Chisel (osteotome) |
| Applicant | WATERSTONE MEDICAL, INC. 7200 WISCONSIN AVE., SUITE 312 BETHESDA, MD 20814 -4807 |
| Contact | DANIEL N TRIBASTONE |
| Correspondent | DANIEL N TRIBASTONE WATERSTONE MEDICAL, INC. 7200 WISCONSIN AVE., SUITE 312 BETHESDA, MD 20814 -4807 |
| Product Code | KDG |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-10 |
| Decision Date | 1995-06-29 |