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FDA 510(k)

PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT

K-Number: K884421 · 1989-01-13

ApplicantPymah Corp.
Decision Date1989-01-13
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT is the device name listed in this FDA 510(k) record. The listed applicant is Pymah Corp.. It received FDA 510(k) clearance on 1989-01-13 under 510(k) number K884421. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT?

PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is Pymah Corp.. The 510(k) number is K884421.

When did PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT receive FDA 510(k) clearance?

PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT received FDA 510(k) clearance on 1989-01-13, under 510(k) number K884421.

Who is the listed applicant for PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT?

The FDA 510(k) record lists Pymah Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT?

The FDA product code for PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT is DXQ.

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Related Devices (Code: DXQ)

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.

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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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