510(k) K882673
- Device
- SIGMA 1 WOBBLER BIOPSY KIT
- Applicant
- KONTRON INSTRUMENTS, INC.
- 510(k) number
- K882673
- Product code
- FCH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-28
- Date received
- 1988-06-28
- Regulation
- 876.4730
- Classification name
- Tray, Biopsy, Without Biopsy Instruments
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID CROMWICK
- Address
- 9 Plymouth St. Everett MA US 02149 02149
FDA Registration Numbers#
- 3005440795
- 1047429
- 3010230734
- 3005595283
- 3044182936
- 1928237
- 8040278
- 3008492462
- 2183446
- 1420054
- 2433012
- 1123010
- 3015173212
- 3004111573
- 1030451
- 1423395
- 3035642068
- 3009558349
- 3004122598
- 2029015
- 1528319
- 2531475
- 2027804
- 3005012805
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852105 | MANAN UBK ULTRASONIC GUIDED BIOPSY KIT | Manan Manufacturing Co., Inc. | 1985-06-18 |
Legacy Summary#
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FDA Review#
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