The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Fisch Drill System.
| Device ID | K792159 |
| 510k Number | K792159 |
| Device Name: | FISCH DRILL SYSTEM |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-29 |
| Decision Date | 1979-11-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17630055508031 | K792159 | 000 |
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