Precision Harvest & Inlay Instrument Set
FDA 510(k) K851339 · Concept, Inc.
510(k) numberK851339
Submission
- Device name
- Precision Harvest & Inlay Instrument Set
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- April 3, 1985
- Decision date
- July 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HWK – Trephine
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
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Questions and answers
When was Precision Harvest & Inlay Instrument Set cleared by the FDA?
Precision Harvest & Inlay Instrument Set (K851339) received a 510(k) decision of Substantially Equivalent on July 2, 1985, 90 days after the submission was received.
What is the product code of K851339?
The FDA product code is HWK – Trephine, a Class I (low risk) device regulated under 21 CFR 888.4540.