WEBERNEEDLE BASIC LASER
FDA 510(k) clearance K073352 · decided 2008-08-11
Clearance details
- K-number
- K073352
- Device name
- WEBERNEEDLE BASIC LASER
- Applicant
- Weber Medical GmbH
- Decision
- Substantially Equivalent
- Date received
- 2007-11-29
- Decision date
- 2008-08-11
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- ILY
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Lauenförde, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.