Sdi C-Flex Sterile Light Handle
FDA 510(k) K834239 · Sterile Design, Inc.
510(k) numberK834239
Submission
- Device name
- Sdi C-Flex Sterile Light Handle
- Applicant
- Sterile Design, Inc.
Walker, MI, US - Received
- December 6, 1983
- Decision date
- April 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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| K834237 | Graduated Guide Wire Bowl 8DQX · Traditional | 02/04/1984SE |
| K813437 | Pan SetFRG · Traditional | 12/31/1981SE |
| K791738 | Custom Dressing Change TraysFMC · Traditional | 10/02/1979SE |
Questions and answers
When was Sdi C-Flex Sterile Light Handle cleared by the FDA?
Sdi C-Flex Sterile Light Handle (K834239) received a 510(k) decision of Substantially Equivalent on April 25, 1984, 141 days after the submission was received.