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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K853541
Device Name SP 4
Applicant
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Applicant Contact ANDREW SCHAEFFER
Correspondent
Robert Bosch Corp.
Flower Field Bldg. #17
Mill Pond Rd.
St. James,  NY  11780
Correspondent Contact ANDREW SCHAEFFER
Date Received08/26/1985
Decision Date 03/28/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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