The following data is part of a premarket notification filed by De Soutter Medical Ltd. with the FDA for The De Soutter M193 Reamer.
| Device ID | K930784 |
| 510k Number | K930784 |
| Device Name: | THE DE SOUTTER M193 REAMER |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | DE SOUTTER MEDICAL LTD. UNIT 1, KINGS PARK PRIMROSE HILL Kings Langley, Herts, GB Wd4 8st |
| Contact | Bernard Gratwicke |
| Correspondent | Bernard Gratwicke DE SOUTTER MEDICAL LTD. UNIT 1, KINGS PARK PRIMROSE HILL Kings Langley, Herts, GB Wd4 8st |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-16 |
| Decision Date | 1993-10-27 |