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FDA 510(k)

S1 VAGINAL PACKING

K-Number: K861443 · 1986-05-06

ApplicantSurgical Specialties, Inc.
Decision Date1986-05-06
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

S1 VAGINAL PACKING is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Specialties, Inc.. It received FDA 510(k) clearance on 1986-05-06 under 510(k) number K861443. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S1 VAGINAL PACKING?

S1 VAGINAL PACKING is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is Surgical Specialties, Inc.. The 510(k) number is K861443.

When did S1 VAGINAL PACKING receive FDA 510(k) clearance?

S1 VAGINAL PACKING received FDA 510(k) clearance on 1986-05-06, under 510(k) number K861443.

Who is the listed applicant for S1 VAGINAL PACKING?

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

What is the FDA product code for S1 VAGINAL PACKING?

The FDA product code for S1 VAGINAL PACKING is EFQ.

Related Clinical Trials

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Other records listing Surgical Specialties, 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.

K932037SUTURE ABSORBABLE- GUTK930826SUTURE NONABSORBABLE - SILKK930825SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLESK932038SUTURE NONABSORBABLE- SILK, POLYESTERK874219S3 MEDICATED GAUZEK861445S1 CAVITY PACKING

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Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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