The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Swiss Lithoclast Master Handpiece And 3.2 Mm Probe.
| Device ID | K974164 |
| 510k Number | K974164 |
| Device Name: | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson MEDICAL DEVICE CONSULTANTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-05 |
| Decision Date | 1997-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613353166038 | K974164 | 000 |
| 07613353116040 | K974164 | 000 |
| 07613353116026 | K974164 | 000 |
| 07613353000509 | K974164 | 000 |
| 07613353000493 | K974164 | 000 |