Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
FDA 510(k) K082396 · C.R. Bard, Inc.
510(k) numberK082396
Submission
- Device name
- Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087
- Applicant
- C.R. Bard, Inc.
Warwick, RI, US - Received
- August 19, 2008
- Decision date
- January 2, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GDW – Staple, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4750
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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Questions and answers
When was Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 cleared by the FDA?
Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 (K082396) received a 510(k) decision of Substantially Equivalent on January 2, 2009, 136 days after the submission was received.
What is the product code of K082396?
The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.