FDA 510(k)

POCKETED WRAPS #3009 A,B,C

K-Number: K891210 · 1989-10-13

ApplicantPro-Safe Professional Linens, Inc.

Decision Date1989-10-13

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POCKETED WRAPS #3009 A,B,C 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 1989-10-13 under 510(k) number K891210. 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 POCKETED WRAPS #3009 A,B,C?

POCKETED WRAPS #3009 A,B,C is a medical device that received FDA 510(k) clearance on 1989-10-13. The listed applicant is Pro-Safe Professional Linens, Inc.. The 510(k) number is K891210.

When did POCKETED WRAPS #3009 A,B,C receive FDA 510(k) clearance?

POCKETED WRAPS #3009 A,B,C received FDA 510(k) clearance on 1989-10-13, under 510(k) number K891210.

Who is the listed applicant for POCKETED WRAPS #3009 A,B,C?

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 POCKETED WRAPS #3009 A,B,C?

The FDA product code for POCKETED WRAPS #3009 A,B,C is KCT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

K891216DENTAL EQUIPMENT PROTECTION DEVICES K891215FAST WRAP #M 101 K891211SURGICAL GOWN #2001 K891212APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE K891213SURGICAL INSTRUMENT POUCH #M102 K891214DENTAL SURGICAL WRAP #3007 A,B,C

View all 7 devices →

Related Devices (Code: KCT)

K253988LiteSet TraysNobel Biocare AB K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.K253187SteriBest® Sterilization Tray SystemMastel Surgical K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG K252854SteriTite 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.