Atlas FDA

DRY TIPS

FDA 510(k) clearance K890734 · decided 1989-03-10

Clearance details

K-number
K890734
Device name
DRY TIPS
Applicant
Microcopy, Div. Neo-Flo, Inc.
Decision
Substantially Equivalent
Date received
1989-02-13
Decision date
1989-03-10
Days to decision
25 days
Clearance type
Traditional
Product code
KHR
Device class
1
Regulation number
872.6050
Medical specialty
Dental
Advisory committee
Dental
Location
Kennesaw, GA, 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
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 (K980783)Irt Management Corp.1998-04-21
GENERAL HYGIENE KIT (K954068)Physician Industries, Inc.1995-11-08
GAUZE SPONGE (K953812)Remington Medical, Inc.1995-10-02
NON-STERILE GAUZE SPONGE (K891054)Dispomed, Inc.1989-05-01
ORTHODONTIC COTTON ROLL HOLDERS (K891354)American Orthodontics1989-04-17
ALGINATE WOOL FIBER (K870383)Adri1987-04-30
BOVO MOISTURE GUARD (K850988)E.H. Medical Co.1985-04-16
DEN-Z-ORB (K780400)Nice-Pak Products, Inc.1978-03-27
ISO-SHIELD SALIVA ABSORBERS (K771908)3M Company1977-11-07

Recalls involving this device

No recalls on record reference this clearance.