Atlas FDA

3 RING ATTACHMENT

FDA 510(k) clearance K864555 · decided 1986-12-01

Clearance details

K-number
K864555
Device name
3 RING ATTACHMENT
Applicant
Professional Medical Services
Decision
Substantially Equivalent
Date received
1986-11-19
Decision date
1986-12-01
Days to decision
12 days
Clearance type
Traditional
Product code
FMF
Device class
2
Regulation number
880.5860
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
North Salt Lake, UT, US
Third-party review
No
Expedited review
No

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

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Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (K252279)Chirana T.Injecta,A.S.2026-04-17
Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (K253068)CMT Health PTE., Ltd.2026-02-23
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EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (K251089)Exelint International, Co.2025-12-12
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Recalls involving this device

No recalls on record reference this clearance.