MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
FDA 510(k) clearance K880509 · decided 1988-04-01
Clearance details
- K-number
- K880509
- Device name
- MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
- Applicant
- Motil Plastics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-10
- Decision date
- 1988-04-01
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- KJC
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bargoed Mid Glamorga, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IN VITRO 2.5X ROLLER BOTTLE (K873137) | In Vitro Scientific Products | 1987-08-24 |
| SYNALON ROLLER BOTTLE (K791049) | Dynatech Laboratories, Inc. | 1979-06-28 |
Recalls involving this device
No recalls on record reference this clearance.