3M Tegaderm HP Transparent Dressing
FDA 510(k) K932422 · 3M Health Care, Ltd.
510(k) numberK932422
Submission
- Device name
- 3M Tegaderm HP Transparent Dressing
- Applicant
- 3M Health Care, Ltd.
St. Paul, MN, US - Received
- May 19, 1993
- Decision date
- December 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGX – Tape And Bandage, Adhesive
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Specialty
- General Hospital
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Questions and answers
When was 3M Tegaderm HP Transparent Dressing cleared by the FDA?
3M Tegaderm HP Transparent Dressing (K932422) received a 510(k) decision of Substantially Equivalent on December 27, 1993, 222 days after the submission was received.
What is the product code of K932422?
The FDA product code is KGX – Tape And Bandage, Adhesive, a Class I (low risk) device regulated under 21 CFR 880.5240.