Cyclopac TENS
FDA 510(k) K801855 · Dow Corning Wright
510(k) numberK801855
Submission
- Device name
- Cyclopac TENS
- Applicant
- Dow Corning Wright
Mchenry, IL, US - Received
- August 4, 1980
- Decision date
- August 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K930188 | Ortholoc(R) Advantim(Tm) Femoral ComponentJWH · Traditional | 08/03/1993SE |
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Questions and answers
When was Cyclopac TENS cleared by the FDA?
Cyclopac TENS (K801855) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 9 days after the submission was received.
What is the product code of K801855?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.