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FDA 510(k)

CIRCULON SYSTEM STEP 1

K-Number: K951022 · 1995-06-12

ApplicantConvatec, A Division of E.R. Squibb & Sons
Decision Date1995-06-12
Product CodeMCY
Advisory CommitteeHO
DecisionUnknown

Device Summary

CIRCULON SYSTEM STEP 1 is the device name listed in this FDA 510(k) record. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. It received FDA 510(k) clearance on 1995-06-12 under 510(k) number K951022. The device is classified under product code MCY. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CIRCULON SYSTEM STEP 1?

CIRCULON SYSTEM STEP 1 is a medical device that received FDA 510(k) clearance on 1995-06-12. The listed applicant is Convatec, A Division of E.R. Squibb & Sons. The 510(k) number is K951022.

When did CIRCULON SYSTEM STEP 1 receive FDA 510(k) clearance?

CIRCULON SYSTEM STEP 1 received FDA 510(k) clearance on 1995-06-12, under 510(k) number K951022.

Who is the listed applicant for CIRCULON SYSTEM STEP 1?

The FDA 510(k) record lists Convatec, A Division of E.R. Squibb & Sons as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CIRCULON SYSTEM STEP 1?

The FDA product code for CIRCULON SYSTEM STEP 1 is MCY.

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Other records listing Convatec, A Division of E.R. Squibb & Sons 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.

K013814ABSORBENT ANTIMICROBIAL WOUND DRESSINGK990964SIGNADRESS DUODERM DRESSINGK984388HA ABSORBENT WOUND DRESSINGK980720NONWOVEN PADK980382NON-WOVEN COMPRESSK974823NONWOVEN DRESSING

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Related Devices (Code: MCY)

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.

K970721DYNA-FLEX MULTI-LAYER COMPRESSION SYSTEMJohnson & Johnson Medical, Inc.K963719CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAYGrand Medical ProductsK960585WOUND CARE COMPRESSION SYSTEM (WCCS)Suncoast Medical Products, Inc.K952334DRESSING CHANGE TRAYBusse Hospital Disposables, Inc.K951021CIRCULON SYSTEM STEP 2Convatec, A Division of E.R. Squibb & SonsK951476E-PACK PROCEDURE KITSETHICON, 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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