Hollister Horizontal Drain/Tube Attachment Device
FDA 510(k) K922739 · Hollister, Inc.
510(k) numberK922739
Submission
- Device name
- Hollister Horizontal Drain/Tube Attachment Device
- Applicant
- Hollister, Inc.
Libertyville, IL, US - Received
- June 8, 1992
- Decision date
- August 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBX – Catheter, Irrigation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Hollister Horizontal Drain/Tube Attachment Device cleared by the FDA?
Hollister Horizontal Drain/Tube Attachment Device (K922739) received a 510(k) decision of Substantially Equivalent on August 6, 1992, 59 days after the submission was received.
What is the product code of K922739?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.