Atlas FDA

RUNYON LARGE VOLUME PARACENTESIS KIT

FDA 510(k) clearance K970187 · decided 1997-02-14

Clearance details

K-number
K970187
Device name
RUNYON LARGE VOLUME PARACENTESIS KIT
Applicant
Gi Supply
Decision
Substantially Equivalent
Date received
1997-01-17
Decision date
1997-02-14
Days to decision
28 days
Clearance type
Traditional
Product code
LRO
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Willington, CT, US
Third-party review
No
Expedited review
No

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OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (K971061)Opportunity, Inc.1997-06-11
OPPORTUNITY INC. GENERAL PURPOSE TRAY (K971062)Opportunity, Inc.1997-06-09
NEUROLOGICAL OR CRANI TRAYS (PACKS) (K932221)Associated Medical Products Co.1997-03-19
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286)Medline Industries, Inc.1997-03-10
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (K965201)Trinity Laboratories, Inc.1997-02-14
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Recalls involving this device

No recalls on record reference this clearance.