Monoject Bone Marrow Biopsy Trays
FDA 510(k) K945109 · Sherwood Medical Co.
510(k) numberK945109
Submission
- Device name
- Monoject Bone Marrow Biopsy Trays
- Applicant
- Sherwood Medical Co.
St. Louis, MO, US - Received
- October 18, 1994
- Decision date
- November 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GAA – Needle, Aspiration And Injection, Disposable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Monoject Bone Marrow Biopsy Trays cleared by the FDA?
Monoject Bone Marrow Biopsy Trays (K945109) received a 510(k) decision of Substantially Equivalent on November 14, 1994, 27 days after the submission was received.
What is the product code of K945109?
The FDA product code is GAA – Needle, Aspiration And Injection, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.