510(k) K830189
- Device
- Cardiovascular Saw Blades
- Applicant
- TEMP MEDICAL PRODUCTS, INC.
- 510(k) number
- K830189
- Product code
- DWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-01-19
- Regulation
- 878.4820
- Classification name
- Blade, Saw, Surgical, Cardiovascular
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- 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#
- 3032391
- 3030733800
- 3010173425
- 3008808049
- 1646747
- 3006897996
- 3018094310
- 3003800209
- 1649518
- 3012494290
- 9613079
- 3035708926
- 9611283
- 1833986
- 3010163695
- 3013557562
- 3002675176
- 3004215117
- 8040278
- 1828288
- 3040335671
- 3005440795
- 9616696
- 3010155648
- 3008902714
- 1836161
- 3015967359
- 1043214
- 9610612
- 3007958831
- 2025102
- 2916714
- 3003965134
- 1625507
- 3009266751
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904352 | CODMAN COLLINS RADIOPARENT STERNAL BLADES | Codman & Shurtleff, Inc. | 1990-11-21 |
| K862474 | HALL STERNUM SAW | Hall Surgical, Division of Zimmer, Inc. | 1986-07-17 |
| K850483 | MICRO-AIRE STERNUM SAW REPLACEMENT BLADES | Micro-Aire Surgical Instruments, Inc. | 1985-03-01 |