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FDA 510(k)

DISPOSA-LOOPS

K-Number: K780548 · 1978-08-21

ApplicantMedi-Spec
Decision Date1978-08-21
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSA-LOOPS is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Spec. It received FDA 510(k) clearance on 1978-08-21 under 510(k) number K780548. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSA-LOOPS?

DISPOSA-LOOPS is a medical device that received FDA 510(k) clearance on 1978-08-21. The listed applicant is Medi-Spec. The 510(k) number is K780548.

When did DISPOSA-LOOPS receive FDA 510(k) clearance?

DISPOSA-LOOPS received FDA 510(k) clearance on 1978-08-21, under 510(k) number K780548.

Who is the listed applicant for DISPOSA-LOOPS?

The FDA 510(k) record lists Medi-Spec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISPOSA-LOOPS?

The FDA product code for DISPOSA-LOOPS is KKX.

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Other records listing Medi-Spec 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.

K833068LAMINARIA JAPONICA CERVICAL DILATORK812694WHISK-RK812426UTERINE ASPIRATION CURETTES(RIGID&FLEX)K801554STERILE CAST PADDINGK800404MEDSPEC OPERATIVE OPTHALMIC KITK800490STERILE DRESSING PACK

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Related Devices (Code: KKX)

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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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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