510(k) K960456
- Device
- DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
- Applicant
- DENVER BIOMATERIALS, INC.
- 510(k) number
- K960456
- Product code
- KDD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-01
- Date received
- 1996-01-30
- Regulation
- 878.4800
- Classification name
- Kit, Surgical Instrument, Disposable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNNE LEONARD
- Address
- 6851 Hwy. 73 Evergreen CO US 80439 80439
FDA Registration Numbers#
- 1221934
- 3010353405
- 3014383382
- 2431166
- 3013980229
- 2029275
- 3004111573
- 2648623
- 3004122598
- 3032747418
- 3017461134
- 3014644369
- 1836161
- 3013466775
- 3007139365
- 2032098
- 3017059795
- 3021006167
- 8030607
- 3008902714
- 3022320321
- 3032579548
- 3044571218
- 3004519921
- 3010583458
- 3016068274
- 1526611
- 3007007790
- 3012358417
- 3014457631
- 1061124
- 3003528228
- 1420054
- 3014615028
- 9680002
- 1055236
- 3015337348
- 3006617885
- 3010380518
- 3022132808
- 3005108347
- 3008676146
- 3042158827
- 3010131137
- 1423537
- 3008132398
- 2183744
- 3010060157
- 3008650117
- 9616872
- 3010155661
- 3013680140
- 1018470
- 3009888344
- 1000614268
- 2245304
- 3008559295
- 3010178296
- 3014421917
- 2953359
- 1223004
- 3017607477
- 3025603301
- 3008824097
- 1422598
- 1721686
- 1061927
- 3006542380
- 9617977
- 3014637079
- 3003807268
- 3045058049
- 9611024
- 3011089435
- 3004598675
- 2433012
- 1417592
- 3003960560
- 3005675811
- 3039169546
Source Documents#
Other 510(k) Records For Product Code KDD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K072814 | CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES | Covidien | 2008-04-16 |
| K011514 | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE | Kencap , Ltd. | 2001-08-13 |
| K971317 | NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS | National Healthcare Mfg. Corp. | 1997-05-08 |
| K936255 | CUSTOM CV PACK | Associated Medical | 1994-03-31 |
| K932219 | SUTURE SET OR LACERATION TRAYS (PACKS) | Associated Medical Products Co. | 1993-07-09 |
| K923176 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1993-06-17 |
| K925905 | KIT, SURGICAL INSTRUMENT, DISPOSABLE | Kay Medical Concepts | 1993-06-16 |
| K924958 | BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY | Medical Insights, Inc. | 1993-06-07 |
| K925215 | STERILE SURGICAL INSTRUMENT TRAYS | American Healthcare Supply Co., Inc. | 1993-06-01 |
| K924117 | DEXIDE LAPAROSCOPIC KITS | Dexide, Inc. | 1993-03-23 |
| K920989 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Ulti-Med Intl., Inc. | 1992-10-19 |
| K920763 | LACERATTION TRAY | Sterile Concepts, Inc. | 1992-09-28 |
| K920516 | GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB | Trinity Laboratories, Inc. | 1992-04-16 |
| K914244 | STERILE CUSTOM SURGICAL KITS | Ulti-Med Intl., Inc. | 1992-02-24 |
| K913049 | SLIP-PRUF-CLINGER | Macbrud Corp. Medical Div. | 1991-09-11 |
Legacy Summary#
summary
FDA Review#
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