510(k) K925905
- Device
- KIT, SURGICAL INSTRUMENT, DISPOSABLE
- Applicant
- KAY MEDICAL CONCEPTS
- 510(k) number
- K925905
- Product code
- KDD
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 1993-06-16
- Date received
- 1992-11-18
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN COUGHLIN
- Address
- 3280-E Peachtree Corners Circl Norcross GA US 30092 30092
FDA Registration Numbers#
- 3045816907
- 3019798849
- 3007139365
- 3013002167
- 3013680140
- 3011499367
- 3025603301
- 3035642068
- 3043648115
- 3030067857
- 1219602
- 2936485
- 3017952668
- 3009889060
- 1211566
- 3013503739
- 3007607706
- 1718873
- 3006673317
- 8030607
- 3023339277
- 3017896419
- 1417592
- 3008650117
- 3034629649
- 3008132398
- 3018503755
- 3004111573
- 3005440795
- 3015895045
- 3045857302
- 3009746061
- 1030451
- 1223004
- 9615765
- 3009996260
- 1824619
- 3031180770
- 3004365956
- 1424263
- 3004598675
- 2648623
- 3010131137
- 3036756245
- 3017461134
- 1643817
- 3008559295
- 8040278
- 3010459874
- 3007123908
- 1047843
- 3003528228
- 3008824097
- 3011280379
- 3013466775
- 3011862887
- 1526711
- 1221934
- 1121091
- 3020468145
- 9681540
- 8010273
- 3042158827
- 2022435
- 1017294
- 3011089435
- 3038220293
- 3016874083
- 1220477
- 2032098
- 3009495876
- 3021006167
- 3018544165
- 3010470577
- 3012536737
- 2433012
- 3013756169
- 3017937325
- 3014257280
- 3010531069
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K960456 | DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY | Denver Biomaterials, Inc. | 1996-04-01 |
| 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 |
| 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#
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FDA Review#
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