Stryker T4 Hytrel (R) Togas
FDA 510(k) K011755 · Stryker Corp.
510(k) numberK011755
Submission
- Device name
- Stryker T4 Hytrel (R) Togas
- Applicant
- Stryker Corp.
Kalamazoo, MI, US - Received
- June 6, 2001
- Decision date
- June 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYU – Accessory, Surgical Apparel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Stryker T4 Hytrel (R) Togas cleared by the FDA?
Stryker T4 Hytrel (R) Togas (K011755) received a 510(k) decision of Substantially Equivalent on June 22, 2001, 16 days after the submission was received.
What is the product code of K011755?
The FDA product code is LYU – Accessory, Surgical Apparel, a Class I (low risk) device regulated under 21 CFR 878.4040.