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FDA 510(k)

CALMPS: BONE, MASTIN, LEWIN, BRAND

K-Number: K930028 · 1993-02-16

ApplicantThomasville Medical Assoc.
Decision Date1993-02-16
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CALMPS: BONE, MASTIN, LEWIN, BRAND is the device name listed in this FDA 510(k) record. The listed applicant is Thomasville Medical Assoc.. It received FDA 510(k) clearance on 1993-02-16 under 510(k) number K930028. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALMPS: BONE, MASTIN, LEWIN, BRAND?

CALMPS: BONE, MASTIN, LEWIN, BRAND is a medical device that received FDA 510(k) clearance on 1993-02-16. The listed applicant is Thomasville Medical Assoc.. The 510(k) number is K930028.

When did CALMPS: BONE, MASTIN, LEWIN, BRAND receive FDA 510(k) clearance?

CALMPS: BONE, MASTIN, LEWIN, BRAND received FDA 510(k) clearance on 1993-02-16, under 510(k) number K930028.

Who is the listed applicant for CALMPS: BONE, MASTIN, LEWIN, BRAND?

The FDA 510(k) record lists Thomasville Medical Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALMPS: BONE, MASTIN, LEWIN, BRAND?

The FDA product code for CALMPS: BONE, MASTIN, LEWIN, BRAND is LXH.

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Other records listing Thomasville Medical Assoc. 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.

K926429VAGINAL SPECULA: CUSCO, GUTTMAN, INFANTK926471MOGAN CIRCUMCISION CLAMPK926535GOMCO CIRCUMCISION CLAMPK926532ENDO CERVICAL CURETTEK926527ROTO FIT BIOPSY FORCEPSK926531HYSTERECTOMY FORCEPS

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Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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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