REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
FDA 510(k) clearance K936018 · decided 1994-02-22
Clearance details
- K-number
- K936018
- Device name
- REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
- Applicant
- R & D Batteries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-16
- Decision date
- 1994-02-22
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- HLJ
- Device class
- 2
- Regulation number
- 886.1570
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Burnsville, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.