Jackson-Pratt Gold Wound Drains with Duraflo II Coating
FDA 510(k) K960955 · Baxter Healthcare Corp
510(k) numberK960955
Submission
- Device name
- Jackson-Pratt Gold Wound Drains with Duraflo II Coating
- Applicant
- Baxter Healthcare Corp
Mcgaw Park, IL, US - Received
- March 11, 1996
- Decision date
- May 22, 1996
- 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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| K974233 | Lysonix Irrigation SystemGBX · Traditional | Lysonix, Inc. | 02/03/1998SE |
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Questions and answers
When was Jackson-Pratt Gold Wound Drains with Duraflo II Coating cleared by the FDA?
Jackson-Pratt Gold Wound Drains with Duraflo II Coating (K960955) received a 510(k) decision of Substantially Equivalent on May 22, 1996, 72 days after the submission was received.
What is the product code of K960955?
The FDA product code is GBX – Catheter, Irrigation, a Class I (low risk) device regulated under 21 CFR 878.4200.