FDA.reportPublic FDA data

PRECEPTIS MEDICAL, INC

Matched from indexed company URL: Precept, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30106109373010610937PRECEPTIS MEDICAL, INC1N2026-01-018401 Wayzata Blvd Suite 110 Golden Valley MN US 55426
10182231018223PRECEPT MEDICAL PRODUCTS, INC.1Y2020-04-25370 Airport Rd ARDEN NC US 28704

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10814707020585Precept® - N95 SURGICAL RESPIRATOR8004385827customerservice@preceptmed.com
10814707020592Precept® - N95 SURGICAL RESPIRATOR - SMALL8004385827customerservice@preceptmed.com
20814707021015Precept® - Full-face Cleanroom Hood with Snap Closure800-438-5827customerservice@preceptmed.com
20814707021022Precept® - Full-face Pullover Cleanroom Hood with Ties800-438-5827customerservice@preceptmed.com
20814707021053Precept® - Legionnaire Surgical Hood with Tape Tab Closure8004385827customerservice@preceptmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
186392038256335K934969DUALGARD FACE SHIELDFXX1994-03-28
186391797103664K891409PRECEPT MICRO-GARD LASER MASKFXX1989-04-07
186391918143191K771409DISP. SURGICAL FACE MASKFXX1977-10-27
186391545486985K770463MASK, SURGICAL, FACE, DISPOSABLEFXX1977-03-23
1657781650463458K221254Hummingbird Tympanostomy Tube SystemETD2022-07-27
1657781156142566K142282HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)ETD2015-04-23
1657782016093639K133921PRECEPTIS TYMPANOSTOMY TUBE INSERTERETD2014-08-22
186391163917447K020474MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95MSH2002-07-23
186391077945937
186391150132041
186391325045440
186391369258742
186391695063180
186391860222404
186391868071135
186391888413967

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FXX41994-03-28
ETD32022-07-27
MSH12002-07-23

PMN#

GUDID#

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