SYNALON ROLLER BOTTLE
FDA 510(k) clearance K791049 · decided 1979-06-28
Clearance details
- K-number
- K791049
- Device name
- SYNALON ROLLER BOTTLE
- Applicant
- Dynatech Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-06-06
- Decision date
- 1979-06-28
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- KJC
- Device class
- 1
- Regulation number
- 864.2240
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- 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 |
|---|---|---|
| MULTISURFACE ROLLER BOTTLE (M.S.R.B.) (K880509) | Motil Plastics , Ltd. | 1988-04-01 |
| IN VITRO 2.5X ROLLER BOTTLE (K873137) | In Vitro Scientific Products | 1987-08-24 |
Recalls involving this device
No recalls on record reference this clearance.