Atlas FDA

LEWIS SAFE SLEEVE

FDA 510(k) clearance K873960 · decided 1987-12-04

Clearance details

K-number
K873960
Device name
LEWIS SAFE SLEEVE
Applicant
Cheri Lewis, D.D.S.
Decision
Substantially Equivalent
Date received
1987-09-28
Decision date
1987-12-04
Days to decision
67 days
Clearance type
Traditional
Product code
EIF
Device class
1
Regulation number
872.4565
Medical specialty
Dental
Advisory committee
Dental
Location
Beverly Hills, CA, 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
MOUTH PROPS (K940785)Worldwide Dental, Inc.1994-10-05
FOCUS FLUID (K830187)Hematology Marketing Assoc.1983-03-01
SULCARINGS (K830116)North Pacific Dental, Inc.1983-02-18

Recalls involving this device

No recalls on record reference this clearance.