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FDA 510(k)

SURGICAL INSTRUMENT POUCH #M102

K-Number: K891213 · 1989-04-14

ApplicantPro-Safe Professional Linens, Inc.
Decision Date1989-04-14
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICAL INSTRUMENT POUCH #M102 is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Safe Professional Linens, Inc.. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K891213. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL INSTRUMENT POUCH #M102?

SURGICAL INSTRUMENT POUCH #M102 is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is Pro-Safe Professional Linens, Inc.. The 510(k) number is K891213.

When did SURGICAL INSTRUMENT POUCH #M102 receive FDA 510(k) clearance?

SURGICAL INSTRUMENT POUCH #M102 received FDA 510(k) clearance on 1989-04-14, under 510(k) number K891213.

Who is the listed applicant for SURGICAL INSTRUMENT POUCH #M102?

The FDA 510(k) record lists Pro-Safe Professional Linens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICAL INSTRUMENT POUCH #M102?

The FDA product code for SURGICAL INSTRUMENT POUCH #M102 is KCT.

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Other records listing Pro-Safe Professional Linens, Inc. as applicant

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.

K891210POCKETED WRAPS #3009 A,B,CK891216DENTAL EQUIPMENT PROTECTION DEVICESK891215FAST WRAP #M 101K891211SURGICAL GOWN #2001K891212APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPEK891214DENTAL SURGICAL WRAP #3007 A,B,C

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Related Devices (Code: KCT)

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.

K253988LiteSet TraysNobel Biocare ABK261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, 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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