Atlas FDA

SIL-MED WASTE FLUID DUMP BAG

FDA 510(k) clearance K891471 · decided 1989-08-15

Clearance details

K-number
K891471
Device name
SIL-MED WASTE FLUID DUMP BAG
Applicant
Sil-Med Corp.
Decision
Substantially Equivalent
Date received
1989-03-15
Decision date
1989-08-15
Days to decision
153 days
Clearance type
Traditional
Product code
KDG
Device class
1
Regulation number
878.4820
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Taunton, MA, US
Third-party review
No
Expedited review
No

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RecordFirmDate
STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT (K952678)Avail-Southwest Division1995-07-10
OMNI-JUG (K952200)Waterstone Medical, Inc.1995-06-29
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POREX QUALITY PLASTIC SURGERY INSTRUMENTS (K872947)Porex Medical1987-08-21
OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5 (K872092)Military Engineering, Inc.1987-06-23
CHERMEL BONE CHISELS (K842824)Cher Mel Corp.1984-08-02
ANDERSON-NEIVERT OSTEOTOME (K772373)Edward Weck, Inc.1978-03-09
NEIVERT OSTEOTOME (K772376)Edward Weck, Inc.1978-03-09
SILVER OSTEOTOME (K772374)Edward Weck, Inc.1978-03-09
CEMENT EXTRACTION INSTRUMENT SET (K780135)Orthopedic Equipment Co., Inc.1978-01-31

Recalls involving this device

No recalls on record reference this clearance.