510(k) K011512
- Device
- MMODIFICATION TO LAMINARIA
- Applicant
- A & A Medical, Inc.
- 510(k) number
- K011512
- Product code
- HDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-09
- Date received
- 2001-05-16
- Regulation
- 884.4260
- Classification name
- Dilator, Cervical, Hygroscopic-Laminaria
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- JIHAD (JAY) MANSOUR
- Address
- 9370 Industrial Trace Alpharetta GA US 30004 30004
FDA Registration Numbers#
- 1319639
- 1450908
- 3005483737
- 1422634
- 1424263
- 8030107
Source Documents#
Other 510(k) Records For Product Code HDY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040625 | ATAD ARD CATHETER | Atad Developments , Ltd. | 2005-01-18 |
| K021012 | LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM | Quality Medical Solusions, LLC | 2002-06-25 |
| K955072 | LAMINARIA | Cti Corp., Ltd. | 1996-05-22 |
| K892220 | LAMINARIA TENT | Berkeley Medevices | 1989-06-14 |
| K881295 | LAMINARIA CUREX | Harold W. Berger Co. | 1988-08-10 |
| K881312 | LAMINARIA | Busse Hospital Disposables, Inc. | 1988-05-23 |
| K880196 | LAMINARIA | Medgyn Products, Inc. | 1988-05-06 |
| K845006 | SUN MEDICAL LAMINARIA CERVICAL DILATOR | Sun Medical, Inc. | 1985-05-01 |
| K833068 | LAMINARIA JAPONICA CERVICAL DILATOR | Medi-Spec | 1984-02-04 |
| K782067 | DILATOR, MIZUTANI LAMINARIA TENT | British Marketing Ent., Ltd. | 1979-01-03 |