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510(k) K981235

OCULOSTAT by Laser Center Dev. Corp. — Product Code HNC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1998
Date Received
April 3, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Laser Center Dev. Corp.

  • K981063 — AUTOMATED CORNEAL TREPHINE (June 23, 1998)

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