Bone Marrow Biopsy System
FDA 510(k) K923872 · The Straumann Co.
510(k) numberK923872
Submission
- Device name
- Bone Marrow Biopsy System
- Applicant
- The Straumann Co.
Cambridge, MA, US - Received
- August 3, 1992
- Decision date
- December 15, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GDM – Needle, Aspiration And Injection, Reusable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K904667 | Na NeedlesGDM · Traditional | Olympus Corp. | 12/12/1990SE |
| K903750 | Islam Sternal Puncture Needle, Cat #AG-598-OO-EGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
| K903749 | Islam Sternal Puncture Needle, Cat #AG-596-00-UGDM · Traditional | Downs Surgical , Ltd. | 10/31/1990SE |
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Questions and answers
When was Bone Marrow Biopsy System cleared by the FDA?
Bone Marrow Biopsy System (K923872) received a 510(k) decision of Substantially Equivalent on December 15, 1992, 134 days after the submission was received.
What is the product code of K923872?
The FDA product code is GDM – Needle, Aspiration And Injection, Reusable, a Class I (low risk) device regulated under 21 CFR 878.4800.