← FDA Medical Device Classifications

Gown, Isolation, Surgical

FYC · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4040

Classification

FDA Product Code

FYC

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 878.4040

Review panel

HO

Medical specialty

General, Plastic Surgery

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

68

Registered establishments

58

Source

Authoritative

FDA Device Classification database

Machine

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