Bone and Marrow Collection System Kit
FDA 510(k) K971782 · Biomedical Ent., Inc.
510(k) numberK971782
Submission
- Device name
- Bone and Marrow Collection System Kit
- Applicant
- Biomedical Ent., Inc.
San Antonio, TX, US - Received
- May 14, 1997
- Decision date
- July 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Bone and Marrow Collection System Kit cleared by the FDA?
Bone and Marrow Collection System Kit (K971782) received a 510(k) decision of Substantially Equivalent on July 29, 1997, 76 days after the submission was received.
What is the product code of K971782?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.