FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

SURGICAL DRAPE & DRAPE ACCESSORIES

K Number: K863732 · Decision Oct 23, 1986
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
6
Review Days
30

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Basic Information

Device Name
SURGICAL DRAPE & DRAPE ACCESSORIES
K Number
K863732
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4370
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Intera Corp.
Date Received
September 23, 1986
Decision Date
October 23, 1986
Product Code
KKX
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KKX Drape, Surgical, Antimicrobial

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (KKX), ordered by most recent decision date.

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Other Clearances by Intera Corp.

K Number Device Name
K891686 LIB SYSTEM, BABY/ADULT DIAPER
K885185 INTERA SHIELD AND INTERA UNDERGARMENT
K883787 REUSABLE ADULT INCONTINENT DIAPER
K883424 SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB
K862380 MATTRESS COVER