FDA 510(k)

EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)

K-Number: K101598 · 2010-10-04

ApplicantExact Medical Manufacturing, Inc.

Decision Date2010-10-04

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) is the device name listed in this FDA 510(k) record. The listed applicant is Exact Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2010-10-04 under 510(k) number K101598. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)?

EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) is a medical device that received FDA 510(k) clearance on 2010-10-04. The listed applicant is Exact Medical Manufacturing, Inc.. The 510(k) number is K101598.

When did EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) receive FDA 510(k) clearance?

EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) received FDA 510(k) clearance on 2010-10-04, under 510(k) number K101598.

Who is the listed applicant for EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)?

The FDA 510(k) record lists Exact Medical Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS)?

The FDA product code for EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) is KKX.

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Other records listing Exact Medical Manufacturing, Inc. as applicant

K121919SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV K120045EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV K111535EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER K101689EMM EQUIPMENT COVER-POLYTHYLENE K101688EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 K101593EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL

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Related Devices (Code: KKX)

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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.