510(k) K801426
- Device
- Tissue-tek Iii Microject Disp. Blade Sys
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K801426
- Product code
- IDL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-07-28
- Date received
- 1980-06-17
- Regulation
- 864.3010
- Classification name
- Microtome, Accessories
- Medical specialty
- Pathology
- Review panel
- Pathology
- 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#
- 3009963993
- 3004973335
- 3013666218
- 1063851
- 3014680809
- 3023034117
- 3008338766
- 3027645317
- 1055757
- 3007496191
- 3030733800
- 3043606682
- 8010478
- 3010973832
- 1119522
- 3014498538
- 1125236
- 3004594181
- 3010692993
- 3010889707
- 3043088937
- 3019387954
- 3005921503
- 3005787343
- 1419341
- 3006982105
- 3043138885
- 9613910
- 2531348
- 1063382
- 1831638
- 3013358456
- 9614636
- 3016788237
- 3008054084
- 8031525
- 1520597
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IDL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K863616 | KNIFE MAKER | Surgipath Medical Industries, Inc. | 1986-09-25 |
| K831921 | DISPOSABLE MICROTOME BLADES | Polymer Technology Corp. | 1983-07-29 |
| K831308 | DISPOSABLE MICROTOME BLADE | Surgipath Medical Industries, Inc. | 1983-05-16 |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | American Optical Corp. | 1981-12-29 |