Atlas FDA

PCM 2000; ISOLAIR APR MODEL 2735

FDA 510(k) clearance K970448 · decided 1997-04-30

Clearance details

K-number
K970448
Device name
PCM 2000; ISOLAIR APR MODEL 2735
Applicant
Tecnol Medical Products, Inc.
Decision
Substantially Equivalent
Date received
1997-02-06
Decision date
1997-04-30
Days to decision
83 days
Clearance type
Traditional
Product code
MSH
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.