MONODERM
Suture, Absorbable, Synthetic, Polyglycolic Acid
SURGICAL SPECIALTIES CORP.
The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Monoderm.
Pre-market Notification Details
| Device ID | K040477 |
| 510k Number | K040477 |
| Device Name: | MONODERM |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-24 |
| Decision Date | 2004-05-18 |
| Summary: | summary |
Trademark Results [MONODERM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MONODERM 78344178 3136533 Live/Registered |
Surgical Specialties Corporation 2003-12-22 |
 MONODERM 75161602 2453386 Dead/Cancelled |
ALZO INTERNATIONAL, INC. 1996-09-06 |
 MONODERM 72380059 0929875 Dead/Expired |
ETHYLENE CORPORATION 1971-01-04 |
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