Drill Modules Models 2116/2117
FDA 510(k) K914346 · Micro Surgical Instruments Corp.
510(k) numberK914346
Submission
- Device name
- Drill Modules Models 2116/2117
- Applicant
- Micro Surgical Instruments Corp.
Valencia, CA, US - Received
- September 27, 1991
- Decision date
- November 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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Questions and answers
When was Drill Modules Models 2116/2117 cleared by the FDA?
Drill Modules Models 2116/2117 (K914346) received a 510(k) decision of Substantially Equivalent on November 27, 1991, 61 days after the submission was received.
What is the product code of K914346?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.