PEMCO, INC.

FDA Device Registration & Listing · Cleveland, OH, US · Registration 1519227

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1519227
FEI Number
1519227
Entity Name
PEMCO, INC.
City/State/Country
Cleveland, OH, US
Establishment Address
5663 BRECKSVILLE RD., Cleveland, OH 44131, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PEMCO, INC. (Owner Number: 1519227)
Owner / Operator Contact Address
5663 BRECKSVILLE RD., --, Cleveland, OH 44131, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PEMCO REUSABLE SUCTION PROBES RULTRACT SKYHOOK RETRACTOR SYSTEMS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MWS Stabilizer, Heart Cardiovascular Class 1 870.4500 2019-11-13
DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass Cardiovascular Class 2 870.4420 2008-03-24
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2003-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PEMCO, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-04 Rultract Inc 1
Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1519227. Last updated year: 2026. Please use registration number 1519227 when referencing this establishment in official correspondence.
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