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FDA 510(k)

IDENTI LOOPS DEGANIA SILICONE

K-Number: K920104 · 1992-04-20

ApplicantPuritas Health Care, Inc.
Decision Date1992-04-20
Product CodeDSS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IDENTI LOOPS DEGANIA SILICONE is the device name listed in this FDA 510(k) record. The listed applicant is Puritas Health Care, Inc.. It received FDA 510(k) clearance on 1992-04-20 under 510(k) number K920104. The device is classified under product code DSS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDENTI LOOPS DEGANIA SILICONE?

IDENTI LOOPS DEGANIA SILICONE is a medical device that received FDA 510(k) clearance on 1992-04-20. The listed applicant is Puritas Health Care, Inc.. The 510(k) number is K920104.

When did IDENTI LOOPS DEGANIA SILICONE receive FDA 510(k) clearance?

IDENTI LOOPS DEGANIA SILICONE received FDA 510(k) clearance on 1992-04-20, under 510(k) number K920104.

Who is the listed applicant for IDENTI LOOPS DEGANIA SILICONE?

The FDA 510(k) record lists Puritas Health Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDENTI LOOPS DEGANIA SILICONE?

The FDA product code for IDENTI LOOPS DEGANIA SILICONE is DSS.

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Other records listing Puritas Health Care, 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.

K942339SKIN NEUVEAU SCAR TREATMENTK941197SILK*SKIN SCAR TREATMENTK935600TRACHEAL SUCTION CATHETERK935531OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIPK940074Y-TYPE BLOOD ADMINISTRATION SETK940055MULTISET

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Related Devices (Code: DSS)

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.

K983744MCAS (MODULAR CLIP APPLIER SYSTEM)Applied Medical ResourcesK961333HEARTPORT MULTIFIRE CLIP APPLIERHeartport, Inc.K920676RMI SOFCLAMPResearch Medical, Inc.K914523CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COILCatheter Research C/O Burditt, Bowles & RadziusK901303HORIZON SURGICAL LIGATING AND MARKING CLIPHorizon Surgical, Inc.K883909SURGICAL SPRING CLIPSApplied Vascular Devices, 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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