Atlas FDA

PIP X-RAY PROTECTIVE GLASSES

FDA 510(k) clearance K837608 · decided 1983-06-27

Clearance details

K-number
K837608
Device name
PIP X-RAY PROTECTIVE GLASSES
Applicant
Pinnacle Intl., Inc.
Decision
Substantially Equivalent
Date received
1983-05-16
Decision date
1983-06-27
Days to decision
42 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Stamford, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.