Medspec Rayon Balls
FDA 510(k) K800277 · Medspec Corp.
510(k) numberK800277
Submission
- Device name
- Medspec Rayon Balls
- Applicant
- Medspec Corp.
Mchenry, IL, US - Received
- February 5, 1980
- Decision date
- March 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRL – Fiber, Medical, Absorbent
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5300
- Specialty
- General Hospital
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| K811990 | Trach Cleaning TrayFRL · Traditional | Associated Medical Products Co. | 07/27/1981SE |
| K810242 | Utensil & Procedure TraysFRL · Traditional | American Hospital Supply Corp. | 04/15/1981SE |
| K800249 | Surgitek Foerster Mammary BandageFRL · Traditional | Medical Engineering Corp. | 02/19/1980SE |
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| K792295 | SorbiesFRL · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
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| K813012 | Sterile Basin SetsLDQ · Traditional | 11/06/1981SE |
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| K812710 | Sterile Laparotomy Sponges-X-Ray DetectGDY · Traditional | 11/02/1981SE |
| K812707 | Sterile Dissector Sponges-X-Ray DetectGDY · Traditional | 11/02/1981SE |
| K812709 | Sterile Dental RollEFN · Traditional | 10/23/1981SE |
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| K810069 | Sterile AirwayCAE · Traditional | 02/02/1981SE |
| K802060 | Sterile Tonsil SpongesGDY · Traditional | 10/10/1980SE |
| K801069 | Sterile Isolation GownFYC · Traditional | 05/20/1980SE |
| K801068 | Sterile Abdominal PadKKX · Traditional | 05/20/1980SE |
Questions and answers
When was Medspec Rayon Balls cleared by the FDA?
Medspec Rayon Balls (K800277) received a 510(k) decision of Substantially Equivalent on March 12, 1980, 36 days after the submission was received.
What is the product code of K800277?
The FDA product code is FRL – Fiber, Medical, Absorbent, a Class I (low risk) device regulated under 21 CFR 880.5300.