Atlas FDA

MODEL 902 STAND

FDA 510(k) clearance K780759 · decided 1978-05-19

Clearance details

K-number
K780759
Device name
MODEL 902 STAND
Applicant
Applied Medical Research
Decision
Substantially Equivalent
Date received
1978-05-08
Decision date
1978-05-19
Days to decision
11 days
Clearance type
Traditional
Product code
FSH
Device class
1
Regulation number
878.4800
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
S 4 INSTRUMENT STAND (K884876)Carl Zeiss, Inc.1988-12-15
S 21 INSTRUMENT STAND (K883578)Carl Zeiss, Inc.1988-09-13
STAND, SURG. INSTRUMENT & DRESSING (K821921)Emerson-Sack-Warner Corp.1982-07-30
SKINNY CHIBA NEEDLE & TRAY (K813337)American Pharmaseal Div. Ahsc1982-01-28
BIOPSY NEEDLES & TRAYS (K813338)American Pharmaseal Div. Ahsc1982-01-28
PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY (K813335)American Pharmaseal Div. Ahsc1982-01-08
FSH RIA KIT (125I) (K772188)Diagnostic Products Corp.1977-12-22

Recalls involving this device

No recalls on record reference this clearance.