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FDA 510(k)

TOME'S #'S 1221,1222,1223,1314,6640,6642

K-Number: K791980 · 1979-10-04

ApplicantEdward Weck, Inc.
Decision Date1979-10-04
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TOME'S #'S 1221,1222,1223,1314,6640,6642 is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1979-10-04 under 510(k) number K791980. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOME'S #'S 1221,1222,1223,1314,6640,6642?

TOME'S #'S 1221,1222,1223,1314,6640,6642 is a medical device that received FDA 510(k) clearance on 1979-10-04. The listed applicant is Edward Weck, Inc.. The 510(k) number is K791980.

When did TOME'S #'S 1221,1222,1223,1314,6640,6642 receive FDA 510(k) clearance?

TOME'S #'S 1221,1222,1223,1314,6640,6642 received FDA 510(k) clearance on 1979-10-04, under 510(k) number K791980.

Who is the listed applicant for TOME'S #'S 1221,1222,1223,1314,6640,6642?

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

What is the FDA product code for TOME'S #'S 1221,1222,1223,1314,6640,6642?

The FDA product code for TOME'S #'S 1221,1222,1223,1314,6640,6642 is HNN.

Other records listing Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

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Related Devices (Code: HNN)

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.

K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.K922378OPHTHALMIC KNIFEMicroptics Development LaboratoryK882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical CenterK881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, 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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