FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
K Number: K982712
·
Decision Dec 18, 1998
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
9
Review Days
136
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Basic Information
- Device Name
- RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
- K Number
- K982712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Date Received
- August 4, 1998
- Decision Date
- December 18, 1998
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K991416 | ENDOSCOPIC CAMERA | Jul 20, 1999 | Substantially Equivalent |
| K991191 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Jun 22, 1999 | Substantially Equivalent |
| K990062 | SAPHLIFT | Mar 30, 1999 | Substantially Equivalent |
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