510(k) K920978
- Device
- ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
- Applicant
- ETHICON, Inc.
- 510(k) number
- K920978
- Product code
- GAN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-02-15
- Date received
- 1992-03-02
- Regulation
- 878.4830
- Classification name
- Suture, Absorbable, Synthetic
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN D PAULSON
- Address
- Rte. 22 W. P.O. Box 151 Somerville NJ US 08876 08876
FDA Registration Numbers#
- 3017102971
- 3014279513
- 3012421607
- 3004845555
- 1221601
- 3005953126
- 3018052045
- 3004944585
- 3013403214
- 1423662
- 3013187142
- 2210968
- 3011137372
- 3010419931
- 1614993
- 3010041511
- 3006638824
- 3001124136
- 3011689956
- 3012502601
- 3007791599
- 3004365956
- 3014461810
- 3007205024
- 1054241
- 2020601
- 1043214
- 1055236
- 3029901632
Source Documents#
Other 510(k) Records For Product Code GAN#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003015 | SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD | Surgical Specialties Corp | 2000-12-15 |
| K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED | ETHICON, Inc. | 1996-12-18 |
| K960653 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) | ETHICON, Inc. | 1996-03-28 |
| K951231 | ORTHOPEDIC PACKS | Sterile Concepts, Inc. | 1995-12-01 |
| K895579 | POLYSORB SYNTHETIC ABSORBABLE SUTURE | United States Surgical, A Division of Tyco Healthc | 1990-07-05 |
| K900198 | DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. | American Cyanamid Co. | 1990-07-05 |