510(k) K780884
- Device
- HYPO-GRIP
- Applicant
- HARCO PRODUCTS
- 510(k) number
- K780884
- Product code
- KZA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-08-10
- Date received
- 1978-05-30
- Regulation
- 880.6970
- Classification name
- Device, Vein Location, Liquid Crystal
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3002736133
- 3027645317
- 2133641
- 3027571036
- 3006475220
- 3042972690
- 3007121351
- 3011120183
- 3009964638
- 3043088937
- 3021011212
- 3013137141
- 3012956357
- 3008161930
- 3010781643
- 3043138885
- 3007048259
- 3015146331
- 3034118952
- 2245574
- 2133810
- 3013685983
- 3013351723
- 1066427
- 3034210589
- 3027501622
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KZA #
Legacy Summary#
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FDA Review#
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