Hydrology 5000
FDA 510(k) K955339 · Northgate Technologies, Inc.
510(k) numberK955339
Submission
- Device name
- Hydrology 5000
- Applicant
- Northgate Technologies, Inc.
Elgin, IL, US - Received
- November 20, 1995
- Decision date
- March 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Hydrology 5000 cleared by the FDA?
Hydrology 5000 (K955339) received a 510(k) decision of Substantially Equivalent on March 13, 1996, 114 days after the submission was received.
What is the product code of K955339?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.