H.V. Pulse Lavage (L31 Series)
FDA 510(k) K970916 · Global Medical Products, Inc.
510(k) numberK970916
Submission
- Device name
- H.V. Pulse Lavage (L31 Series)
- Applicant
- Global Medical Products, Inc.
Las Vegas, NV, US - Received
- March 12, 1997
- Decision date
- June 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FQH – Lavage, Jet
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5475
- Specialty
- General Hospital
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| K951421 | Global Medical Products Chiba, Franseen, Westcott Style, Menghini, Turner, Greene NeedlesFCG · Traditional | 11/16/1995SE |
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Questions and answers
When was H.V. Pulse Lavage (L31 Series) cleared by the FDA?
H.V. Pulse Lavage (L31 Series) (K970916) received a 510(k) decision of Substantially Equivalent on June 20, 1997, 100 days after the submission was received.
What is the product code of K970916?
The FDA product code is FQH – Lavage, Jet, a Class II (moderate risk) device regulated under 21 CFR 880.5475.