510(k) K921730
- Device
- C-SECTION PACK
- Applicant
- MEDIKMARK, INC.
- 510(k) number
- K921730
- Product code
- KOH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-06-15
- Date received
- 1992-04-10
- Regulation
- 884.4520
- Classification name
- Instrument, Manual, General Obstetric-gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD O WOOD
- Address
- 333 W. Wacker Dr. Suite 2600 Chicago IL US 60606 60606
FDA Registration Numbers#
- 3008403546
- 3007123908
- 9611112
- 3005440795
- 3005595283
- 8010370
- 9615857
- 9610617
- 1421879
- 1056350
- 3009703496
- 8040278
- 8010099
- 3010041511
- 1923569
- 3015173212
- 3004519921
- 3009340886
- 3008496560
- 2124215
- 3005273623
- 3014902417
- 9611273
- 1836161
- 1225580
- 3008388245
- 9680515
- 3003644849
- 3005092287
- 8040884
- 2434839
- 3013503739
- 3005813597
- 2125050
- 3006210673
- 2023739
- 9616250
- 3011137372
- 3004859928
- 3007137643
- 3010202439
- 8010257
- 3002807314
- 8040233
- 3013846070
- 8010298
- 2916714
- 3003431869
- 9613083
- 1450908
- 5906
- 8043769
- 2246552
- 9612074
- 3007648354
- 1216677
- 8043496
- 1416666
- 9610612
- 3014195785
- 3006546082
- 2084346
- 9710524
- 9611274
- 3013055490
- 3005067367
- 3006554912
- 2020550
- 1222773
- 3043007473
- 3007031059
- 3005099803
- 3014342096
- 3008770252
- 3009865268
- 1926681
- 3003877407
- 8030607
- 1422634
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KOH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K000212 | KSEA CHARDONNES MORCELLATION KNIFE | KARL STORZ Endoscopy-America, Inc. | 2000-04-21 |
| K921732 | MINOR LAP SET | Medikmark, Inc. | 1994-06-15 |
| K891351 | NEWPORT LATERAL VAGINAL RETRACTOR | Simpson/Basye, Inc. | 1989-05-11 |
| K892693 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Zinnanti Surgical Instruments, Inc. | 1989-05-11 |
| K891035 | NEEDLE EXTENSIONS | Zinnanti Surgical Instruments, Inc. | 1989-03-22 |
| K891049 | ZEPPELIN SCISSORS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 |
| K863610 | THE OB-GYN CONCEPTS VAGINAL ASPIRATOR | Ob/Gyn Concepts, Ltd. | 1987-01-07 |
| K840308 | CAT. 4-OBSTETRICS GYNECOLOGY DEV'S | Imm Enterprises , Ltd. | 1984-03-05 |
| K823792 | QUARTZ RETRACTOR/PROBE | American V. Mueller | 1983-01-18 |
| K812204 | UTERINE MANIPULATORS | Reznik Instruments | 1981-10-13 |
| K800834 | SER-TEX | V.S.S.I., Inc. | 1980-06-30 |
| K790851 | VAGI-PRESS #401 | C. Intl. | 1979-07-30 |
| K781767 | INSTRUMENT CURNETT MINI-CONER BIOPSY | C.R. Bard, Inc. | 1978-12-07 |
| K780460 | DENTAL AIR BRUSH | M. Joel Gebhart, D.D.S. | 1978-06-28 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases