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FDA 510(k)

DRAIN-R-DRAPE(EYE

K-Number: K831340 · 1983-06-08

ApplicantSur-Tech, Inc.
Decision Date1983-06-08
Product CodeHMT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAIN-R-DRAPE(EYE is the device name listed in this FDA 510(k) record. The listed applicant is Sur-Tech, Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831340. The device is classified under product code HMT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAIN-R-DRAPE(EYE?

DRAIN-R-DRAPE(EYE is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Sur-Tech, Inc.. The 510(k) number is K831340.

When did DRAIN-R-DRAPE(EYE receive FDA 510(k) clearance?

DRAIN-R-DRAPE(EYE received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831340.

Who is the listed applicant for DRAIN-R-DRAPE(EYE?

The FDA 510(k) record lists Sur-Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAIN-R-DRAPE(EYE?

The FDA product code for DRAIN-R-DRAPE(EYE is HMT.

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Related Devices (Code: HMT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEVisitec Co.K905460STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERYAngiosystems, Inc.K872620SOLOS EYESITE DRAPESSolos OphthalmologyK871706OPTHA PREPTreace Medical, Inc.K854613SURGICAL DRAPES, OPHTHALMINCharles Atkins & Co.K830822EYE DRAPECooperVision, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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