PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501— 510(k) K091097
Substantially EquivalentPromedical Products Co., Ltd.
FDA 510(k) clearance K091097 for PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501, Substantially Equivalent on 2009-05-27. Applicant: Promedical Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Promedical Products Co., Ltd.
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Depew, NY, US
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More clearances from Promedical Products Co., Ltd.
view all- K080629 — PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS
- K080627 — PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A
- K042111 — PROMEDICAL SURGICAL GOWNS
- K042131 — PROMEDICAL SURGICAL DRAPES
- K042137 — PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.