Surgitek Foerster Face Lift Bandage
FDA 510(k) K800248 · Medical Engineering Corp.
510(k) numberK800248
Submission
- Device name
- Surgitek Foerster Face Lift Bandage
- Applicant
- Medical Engineering Corp.
Mchenry, IL, US - Received
- February 6, 1980
- Decision date
- February 19, 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 |
| K800277 | Medspec Rayon BallsFRL · Traditional | Medspec Corp. | 03/12/1980SE |
| K800249 | Surgitek Foerster Mammary BandageFRL · Traditional | Medical Engineering Corp. | 02/19/1980SE |
| K792295 | SorbiesFRL · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
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| 510(k) | Device | Decision |
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| K934141 | Stand Alone CystometrogramFEN · Traditional | 11/18/1993SE |
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| K903448 | Surgitek Tex-Span Textured Tissue ExpanderLCJ · Traditional | 01/14/1991SE |
| K902773 | Surgitek(R) Flexible Ureteroscopy Intro/Sheath SetFGB · Traditional | 07/16/1990SE |
| K884746 | Surgitek Flat T-SpanLCJ · Traditional | 08/10/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | 02/08/1989SE |
| K881736 | Surgitek CO2 Delivery SystemFAP · Traditional | 08/11/1988SE |
| K880802 | Surgitek Articulating Ureteroscope Model SU-11FGB · Traditional | 05/26/1988SE |
| K880801 | Surgitek Flexible Ureteroscope SU-7 & SU-9FGB · Traditional | 05/26/1988SE |
| K842748 | Surgitek Reconstruc-Nipple Prosthesis · Traditional | 09/26/1984SE |
Questions and answers
When was Surgitek Foerster Face Lift Bandage cleared by the FDA?
Surgitek Foerster Face Lift Bandage (K800248) received a 510(k) decision of Substantially Equivalent on February 19, 1980, 13 days after the submission was received.
What is the product code of K800248?
The FDA product code is FRL – Fiber, Medical, Absorbent, a Class I (low risk) device regulated under 21 CFR 880.5300.