510(k) K951911
- Device
- Gauze, Nonabsorabable, X-ray Detectable (internal Sponge)
- Applicant
- COMMERCIAL RESOURCES NEW MEXICO, LTD.
- 510(k) number
- K951911
- Product code
- GDY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-21
- Date received
- 1995-04-24
- Regulation
- 878.4450
- Classification name
- Gauze/Sponge, Internal, X-Ray Detectable
- 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
- M. J HIGA
- Address
- 1900 S. Telshor Blve. Suite A Las Cruces NM US 88011 88011
FDA Registration Numbers#
- 2028046
- 9681385
- 3015173212
- 3012050423
- 2024311
- 1423537
- 2029275
- 3006538822
- 9610612
- 3030455652
- 3003636207
- 3034669683
- 2244478
- 9680708
- 3027605727
- 3008044603
- 3007289408
- 3007299770
- 3014257280
- 3034629649
- 3006897996
- 3021389253
- 3010175283
- 1423395
- 3003887292
- 3011434305
- 1625425
- 2086043
- 8010177
- 3009486864
- 2649614
- 2648623
- 3030067857
- 1018120
- 8030128
- 2032112
- 9616088
- 1047843
- 3012598266
- 3018094310
- 3004784537
- 3032960221
- 1048735
- 9613778
- 3004950768
- 3011529314
- 3016758972
- 8030654
- 1054241
- 2245304
- 3016452400
- 3013502418
- 3014314985
- 3005951296
- 3011816517
- 3042032212
- 3007082891
- 3004519921
- 1220477
- 1923569
- 3010220595
- 3016659819
- 9611959
- 1219313
- 1422598
- 1921846
- 3025413691
- 1422634
- 2024980
- 3038718579
- 1055236
- 3003361112
- 1225532
- 3038162648
- 3004111573
- 9612051
- 9680271
- 1644312
- 3008851420
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972634 | ULTRACELL SUCTION SPONGE | Ultracell Medical Technologies, Inc. | 1997-12-17 |
| K960236 | CPR LAP SPONGES | Custom Pack Reliability | 1996-03-28 |
| K955599 | STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGE | Stryker Corp. | 1996-02-22 |
| K955322 | PROTEC X-RAY DETECTABLE GAUZE SPONGE | Derivados DE Gasa, S.A. DE C.V. | 1995-12-19 |
| K953830 | KENSORB | Kentron Health Care, Inc. | 1995-10-03 |
| K953088 | TRIANGULAR SPONGES | Medical Perspectives Corp. | 1995-09-14 |
| K953087 | CHERRY PIT DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953062 | CHERRY DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953060 | ROSEBUD DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953059 | KITTNER DISSECTOR | Medical Perspectives Corp. | 1995-09-14 |
| K953058 | ROUND STICK SPONGES, FLAT STICK SPONGES | Medical Perspectives Corp. | 1995-09-14 |
| K953057 | CYLINDRICAL SPONGE | Medical Perspectives Corp. | 1995-09-14 |
| K950372 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 |
| K950370 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 |
| K950373 | ULTRACELL ORTHOPEDIC SPONGES | Ultracell Medical Technologies, Inc. | 1995-04-17 |