Olympic Auto-Length
FDA 510(k) K934930 · Olympic Medical Corp.
510(k) numberK934930
Submission
- Device name
- Olympic Auto-Length
- Applicant
- Olympic Medical Corp.
Seattle, WA, US - Received
- October 14, 1993
- Decision date
- December 29, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FTY – Tape, Measuring, Rulers And Calipers
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Olympic Auto-Length cleared by the FDA?
Olympic Auto-Length (K934930) received a 510(k) decision of Substantially Equivalent on December 29, 1993, 76 days after the submission was received.
What is the product code of K934930?
The FDA product code is FTY – Tape, Measuring, Rulers And Calipers, a Class I (low risk) device regulated under 21 CFR 878.4800.