FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

SAMPLING KIT

K Number: K801146 · Decision Jun 4, 1980
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
57
Applicant Total
5
Review Days
22

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Basic Information

Device Name
SAMPLING KIT
K Number
K801146
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
868.1100
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Pharmaseal Laboratories
Date Received
May 13, 1980
Decision Date
June 4, 1980
Product Code
CBT
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

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

Product Code Device Name
CBT Arterial Blood Sampling Kit

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Other Clearances by Pharmaseal Laboratories

K Number Device Name
K800737 DEBRISAN (DEXTRANOMER) PASTE
K800874 PELVIC EXAM TRAY
K800362 FLUID DISPENSING SYSTEM
K760469 CLEANSING AGENT, NEW WOUND (DEBRISSU)