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FDA 510(k)

DENTAL COTTON ROLLS, STERILE AND NON-STERILE

K-Number: K861338 · 1986-08-06

ApplicantIntl. Verbandstoff-Fabrik Schaffhau
Decision Date1986-08-06
Product CodeEFN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL COTTON ROLLS, STERILE AND NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Verbandstoff-Fabrik Schaffhau. It received FDA 510(k) clearance on 1986-08-06 under 510(k) number K861338. The device is classified under product code EFN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL COTTON ROLLS, STERILE AND NON-STERILE?

DENTAL COTTON ROLLS, STERILE AND NON-STERILE is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Intl. Verbandstoff-Fabrik Schaffhau. The 510(k) number is K861338.

When did DENTAL COTTON ROLLS, STERILE AND NON-STERILE receive FDA 510(k) clearance?

DENTAL COTTON ROLLS, STERILE AND NON-STERILE received FDA 510(k) clearance on 1986-08-06, under 510(k) number K861338.

Who is the listed applicant for DENTAL COTTON ROLLS, STERILE AND NON-STERILE?

The FDA 510(k) record lists Intl. Verbandstoff-Fabrik Schaffhau as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL COTTON ROLLS, STERILE AND NON-STERILE?

The FDA product code for DENTAL COTTON ROLLS, STERILE AND NON-STERILE is EFN.

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.

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Other records listing Intl. Verbandstoff-Fabrik Schaffhau 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.

K841327DENTAL COTTON ROLLS

Related Devices (Code: EFN)

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.

K872810STRUNG DENTAL ROLLSAmerican Silk Sutures, Inc.K871464MEDGROUP ENTERPRISES COTTON GAUZE SPONGES-NON STERMedgroup Enterprises, Inc.K863764COTTON ROLLS, NON-STERILEThe Medical Group, Inc.K861727COTTON FILLED GAUZE SPONGES 2 X 2Cross Country Paper Products Corp.K843539TELEDYNE DENSCO DRY TIPS SALIVA ABSORB-Molnlycke A/S Hospital ProductsK841327DENTAL COTTON ROLLSIntl. Verbandstoff-Fabrik Schaffhau

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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