FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
K Number: K880509
·
Decision Apr 1, 1988
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
2
Applicant Total
1
Review Days
51
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Basic Information
- Device Name
- MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
- K Number
- K880509
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2240
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Motil Plastics , Ltd.
- Date Received
- February 10, 1988
- Decision Date
- April 1, 1988
- Product Code
- KJC
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| KJC | Bottle, Roller, Tissue Culture | FDA class 1 | Hematology |
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