SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509
FDA 510(k) clearance K922716 · decided 1992-10-23
Clearance details
- K-number
- K922716
- Device name
- SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509
- Applicant
- Splash Shield, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-05
- Decision date
- 1992-10-23
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- FXX
- Device class
- 2
- Regulation number
- 878.4040
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Woburn, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.