FDA 510(k)

HIGH VAC

K-Number: K920492 · 1992-05-11

Decision Date1992-05-11

Product CodeDYN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HIGH VAC is the device name listed in this FDA 510(k) record. The listed applicant is Hygoplastic, Inc.. It received FDA 510(k) clearance on 1992-05-11 under 510(k) number K920492. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIGH VAC?

HIGH VAC is a medical device that received FDA 510(k) clearance on 1992-05-11. The listed applicant is Hygoplastic, Inc.. The 510(k) number is K920492.

When did HIGH VAC receive FDA 510(k) clearance?

HIGH VAC received FDA 510(k) clearance on 1992-05-11, under 510(k) number K920492.

Who is the listed applicant for HIGH VAC?

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

What is the FDA product code for HIGH VAC?

The FDA product code for HIGH VAC is DYN.

Related Devices (Code: DYN)

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.

K940769DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTORTerraflex K935616SALIVA EJECTOR DISPOSABLEAsa Instruments S.R.L.K935758HYGOFLEX SALIVA-EJECTORJ.H.Orsing AB K924211EJECTORGlenroe Technologies K921117MINIDAMDelsan Dental Systems K900631SALIVA ABSORBER - DENTALKab Gloves Unltd.

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.