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510(k) K871865

SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE by Sharplan Lasers, Inc. — Product Code LNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1987
Date Received
May 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser For Gastro-Urology Use
Device Class
Class II
Regulation Number
878.4810
Review Panel
GU
Submission Type

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Other clearances for product code LNK

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  • K880256 — MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE (April 14, 1988)
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  • K875039 — ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY (April 13, 1988)
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  • K871934 — MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE (March 25, 1988)
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