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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectacle, Operating (Loupe), Ophthalmic
510(k) Number K875124
Device Name LOW-POWER BINOCULAR LOUPE
Applicant
Seiler Instrument & Mfg. Co., Inc.
170 E. Kirkham
St. Louis,  MO  63119
Applicant Contact PEARL REILLY
Correspondent
Seiler Instrument & Mfg. Co., Inc.
170 E. Kirkham
St. Louis,  MO  63119
Correspondent Contact PEARL REILLY
Regulation Number886.4770
Classification Product Code
HOH  
Date Received12/15/1987
Decision Date 02/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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