FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS

K Number: K871604 · Decision Jun 12, 1987
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
9
Applicant Total
64
Review Days
49

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Basic Information

Device Name
MVS 19 AND MVS 20 GAUGE SCLERAL PLUGS
K Number
K871604
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
886.4155
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Applicant
Advanced Surgical Products, Inc.
Date Received
April 24, 1987
Decision Date
June 12, 1987
Product Code
LXP
Advisory Committee
Ophthalmic
Review Advisory Committee
OP
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LXP Plug, Scleral

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Other Clearances by Advanced Surgical Products, Inc.

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K896754 I/A HANDPIECE
K896305 MULTI-USE I/A HANDPIECE
K884557 ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884556 DREYER CURVED ENDOILLUMINATOR
K890398 RYAN-STYLE DIRECTED INFUSION MANIPULATOR
K884347 MODIFIED DISPOSABLE COAXIAL BIPOLAR PEN
K883857 FIBEROPTIC WIRE PICK LIGHTPIPE
K883858 FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
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